Managing the FDA form "483": Inspection Observations

Duration: 60 Minutes
flat 50% off on this webinar
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.
How to Respond to a 483
Instructor: Casper E Uldriks
Product ID: 503502
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.

Areas Covered
  • 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)
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
Topic Background
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.
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Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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