FDA 483, Warning Letters, Other Agency Citations
- 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
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”
“…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....”
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."
“…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 whom 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...“
“…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...”
“…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...”
“…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…”
“…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...”
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