FDA 483, Warning Letters, Other Agency Citations

Common Questions:

How should I respond to my Form FDA 483 or Warning Letter?
Is my ISO/EC certificate in jeopardy?
What ramifications are there from my Warning Letter
Who authorizes/writes/issues FDA Warning Letters?
What are the regulatory consequences of a Warning Letter?
Why has FDA sent me an untitled letter?
Are my approved or pending regulatory submissions at risk?
Will our competitors and customers know about our deficiencies?
How much detail and what promises should we make in our response?
How do we deal with factually inaccurate observations?
What if the citations misinterpret the regulations?
Should we seek a meeting with the FDA District Director or Compliance Officer about our 483 or Warning Letter?

ComplianceAcuity has organic answers to these questions because we’ve forged a proven track record of effective responses to FDA-483’s and Warning Letters. After receipt of a Form FDA 483, Warning Letter, or other Agency citation, the most crucial immediate factor for averting further official actions (i.e., seizures, fines, injunctions, etc.), is to achieve a proper formal first response in conformity with the Agency’s corresponding protocols and expectations. Such a response is ensured by ComplianceAcuity’s experienced, statutorily-adept approach, where we help you devise a comprehensive, yet sustainable, written corrective action plan detailing how the objectionable conditions have been, or will be, resolved.

Tactically speaking, ComplianceAcuity corrective action plans are carefully devised and address not only the specific symptoms cited by the Agency, but also any systemic implications. Our plans are anchored by ComplianceAcuity’s certified fluency in a wide range of regulations and proven best-practices. Take a look at the case studies on this page or our topic-specific client testimonials for an overview of how we restored our clients’ compliance status by using:

“best-practices” compliance techniques
a proven response approach
vital insight regarding “behind-the-scenes” FDA activity
genuine sensitivity to your firm’s economics, business culture, and infrastructure constraints

CASE STUDIES:

Successfully Remediating Major FDA Citations

Successfully Remediating Major Quality System Deficiencies

As our case studies demonstrate, ComplianceAcuity will:

Help you avoid common mistakes made when responding to FDA-483’s and Warning Letters
Develop realistic corrective/preventive action plans based on industry best-practices
Strategically devise and monitor your compliance plan
Intelligently interface with FDA on your behalf. (Please visit our ‘Liaison with Regulatory Agencies’ page
Provide solutions that fit with your unique cultural and organizational needs to ensure your corrective actions “stick”

Testimonials

“...From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to activate a CAPA and how to justify otherwise. This resulted in our team spending time on the highest priority activities (as recognized by regulators) as compared to our previous prioritization which was causing dilution of our efforts...”
, Director, Regulatory Affairs and Quality Assurance

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2001-01-23acuity_admin719
“...From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to activate a CAPA and how to justify otherwise. This resulted in our team spending time on the highest priority activities (as recognized by regulators) as compared to our previous prioritization which was causing dilution of our efforts...”
55stars
“...From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to activate a CAPA and how to justify otherwise. This resulted in our team spending time on the highest priority activities (as recognized by regulators) as compared to our previous prioritization which was causing dilution of our efforts...”

“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“
, Director of Operations – Class III device Manufacturer & Distributor

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2016-02-06acuity_admin719
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“
55stars
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“

“…The bottom line is that, due to ComplianceAcuity's efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his Associates...”
, CEO – Class II device Manufacturer

|
2016-09-28acuity_admin719
“…The bottom line is that, due to ComplianceAcuity's efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his Associates...”
55stars
“…The bottom line is that, due to ComplianceAcuity's efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his Associates...”

“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”
, Director, Regulatory Affairs & Quality Assurance, Class II devices

|
2016-09-28acuity_admin719
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”
55stars
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”

"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

, President & CEO - Class II device Manufacturer

|

2016-09-28acuity_admin719
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."
55stars
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”
, Quality Manager, Class II devices

|
2016-09-28acuity_admin719
“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”
55stars
“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”

“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”
, CEO – Class II device Manufacturer

|
2016-09-28acuity_admin719
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”
55stars
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”

"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
, COO - Class II device Manufacturer

|
2016-09-28acuity_admin719
"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."
55stars
"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."

“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”
, Customer Service Supervisor – Class II & III device Manufacturer

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2016-09-28acuity_admin719
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”
55stars
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”

“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”
, CEO – Class II device Manufacturer

|
2016-09-28acuity_admin719
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”
55stars
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”

“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”
, Director of Operations – Class II and III device Manufacturer

|
2016-09-28acuity_admin719
“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”
55stars
“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”

“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”
, President & Founder – Virtual Manufacturer of Class II devices

|
2016-09-28acuity_admin719
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”
55stars
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”
, Director of Operations – Class II and III device Manufacturer

|
2016-09-28acuity_admin719
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”
55stars
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

“…ComplianceAcuity taught us how to understand and speak FDA’s language...”
, Director of Operations – Class III device Manufacturer & Distributor

|
2016-09-28acuity_admin719
“…ComplianceAcuity taught us how to understand and speak FDA’s language...”
55stars
“…ComplianceAcuity taught us how to understand and speak FDA’s language...”

“…The systems you delivered are highly customized to meet our compliance requirements and business needs. All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover: 1. Compliance and regulatory understanding, was/is not wide-spread. 2. Having the skill sets and time to create Policies/Procedures/Work Instructions. Having [ComplianceAcuity’s] regulatory expertise combined with the documentation skills added immense value since we were trying to run the current system while creating a new one. You certainly brought a high level of expertise and professionalism, mixed with enough humor to keep us all sane!”

, 12-year veteran in various positions including Director of Quality

|

“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
, Director of Quality – Class II & III device Manufacturer

|
2016-09-28acuity_admin719
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
55stars
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”

“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”
, Sr. Process & Quality Manager

|
2016-09-28acuity_admin719
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”
55stars
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”
, Director of Operations – Class III device Manufacturer & Distributor

|
2016-09-28acuity_admin719
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”
55stars
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”

“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”

, Quality Assurance Manager – Class II and III device Manufacturer

|

2016-09-28acuity_admin719
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”
55stars
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”

“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
, Director of Operations – Class II and III device Manufacturer

|
2016-09-28acuity_admin719
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”
55stars
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”
, Sr. QA Manager, Design & Development

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2016-09-28acuity_admin719
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”
55stars
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”
, QA Manager – Class II device Manufacturer

|
2016-09-28acuity_admin719
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”
55stars
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”

“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”

, Quality Assurance Manager – Class II and III device Manufacturer

|

2016-09-28acuity_admin719
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”
55stars
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”

“…We were quite impressed with your abilities...”
, QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices

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2016-09-28acuity_admin719
“…We were quite impressed with your abilities...”
55stars
“…We were quite impressed with your abilities...”

“…I appreciate all the assistance you have provided and look forward to working with you in the future...”

, Business Development – Class II Device Virtual Manufacturer

|

2016-09-28acuity_admin719
“…I appreciate all the assistance you have provided and look forward to working with you in the future...”
45stars
“…I appreciate all the assistance you have provided and look forward to working with you in the future...”

“…ComplianceAcuity ensured that our best interests were always priority #1...”
, QA Manager – Class II device Manufacturer

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2016-09-28acuity_admin719
“…ComplianceAcuity ensured that our best interests were always priority #1...”
55stars
“…ComplianceAcuity ensured that our best interests were always priority #1...”

“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”
, Sr. Quality Engineer – Class II & III device Manufacturer

|
2016-09-28acuity_admin719
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”
55stars
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”

“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”
, Senior Process and Quality Manager

|
2016-09-28acuity_admin719
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”
55stars
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”

“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”
, Director of Operations – Class III device Manufacturer & Distributor

|
2016-09-28acuity_admin719
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”
55stars
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”

“…Kevin responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
, Director of Quality – Class II & III device Manufacturer

|
2016-09-28acuity_admin719
“…Kevin responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”
55stars
“…Kevin responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”

“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”

, President – Class II & III device Manufacturer

|

2021-07-21acuity_admin719
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”
55stars
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”

More Testimonials

Call Us Now +1 303.828.0844

Email Us [email protected]

Our Company Ridgway, CO 81432, USA

FDA 483, Warning Letters, Other Agency Citations

Testimonials

"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”

“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”

“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”

"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."

"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."

"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."

“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”

“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”

“…You are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”

“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

“…ComplianceAcuity taught us how to understand and speak FDA’s language...”

“…ComplianceAcuity taught us how to understand and speak FDA’s language...”

“…ComplianceAcuity taught us how to understand and speak FDA’s language...”

“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”

“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”

“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”

“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”