FDA inspections look for noncompliance with applicable manufacturing regulations. During the inspection the FDA investigator makes a "list of observations" that gives examples of violations. The list is known as the "483." Some observations are very serious and can easily lead to receiving a Warning Letter, which threatens legal action. Your response to a 483 plays a critical role in how the agency will evaluate the inspection. A poorly written response or not responding at all will certainly lead to a Warning Letter and follow up action by FDA.
Objectives of the Presentation
- How to respond to a 483
- How to interpret the 483
- What to say and not say when FDA issues the 483
- Submitting your written response to the 483 observations
Why Should you Attend
Firms should start preparing their response to a 483 during the inspection. Listen to the FDA's concerns then determine what you can do about it. You should know how to structure your response, provide documentation and, if appropriate, provide for periodic or follow up action. At the conclusion of an inspection firms invariably ask, "So, how did we do?" The FDA investigator cannot tell you, but you can answer your own question with the information provided in the webinar.
- Inspection procedure for identifying noncompliant practices
- Discussions during the inspection with the FDA
- Planning for the discussion with FDA at the conclusion of the inspection
- The firm's 483 response team
- Organization of your written response
- Use of FDA's Compliance Program Guidance Manual (CPGM)
FDA is authorized to inspect regulated facilities and point out problems. How a firm responds to the inspection and how it plans to correct the problems has a significant impact on how FDA treats the firm after an inspection. Firms usually do not know the key points that sway FDA's evaluation and classification of an inspection. What you say and how you say it has a major impact. This information is fundamental to any FDA regulated firm.
ex-FDA Expert and former Associate Center Director ,
Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.
Who will Benefit
- Regulatory Affairs Director
- Manufacturing Director/Manager
- Quality Assurance Manager
- Production Managers
- Operations Finance Managers
- Complaint Department Manager
- Product Development and Support Manager