Managing the FDA form “483”: Inspection Observations

This webinar is a complete guide on how to manage the FDA’s 483 observations during and after an inspection. How you respond can make or break you.

Form FDA 483 is a list of observations made by FDA during an inspection. Observations are not a good thing. At the conclusion of an inspection, the FDA investigator lists specific examples that demonstrate an apparent violation of the applicable FDA regulations. You and the FDA investigator will discuss what the investigator found. At that point you are put on notice about your problems. You are warned that if you fail to correct the problems, it may result in further action by the FDA, such as levying civil money penalties, seizure, injunction, and/or prosecution. Firms are well advised to take the written 483 observations and FDA’s verbal warning seriously. A failure to promptly respond in writing to the FDA makes the situation even worse. As an immediate business consequence, marketing departments should expect competitors to show customers your 483. Your 483 is used against you as a bad report.

Prior to an inspection, the FDA investigator reviews your prior 483s and checks to make sure you corrected your previous problems. You will be held accountable for your prior response. What you promised to correct and what you did not correct becomes a critical factor in how FDA classifies your firm. What you fail to correct may lay for the foundation for long-term serious consequences with FDA. Your firm’s management is held accountable for its failure to adequately correct its regulatory problems. In some cases, the FDA will hold senior executive management personally liable for their managerial actions or inaction. Again, what a firm promises and what a firm does in response to a 483 makes a real differenc

Areas Covered in the Session :

• What the Form FDA “483” means
• How to manage the FDA’s 483 observations during and after an inspection
• What the FDA considers important
• How to respond effectively to 483 observations
• Planning for other problems
• Learn how to manage your regulatory profile with the FDA

Who Should Attend:

• Regulatory Affairs Professionals
• In-house Legal Counsel
• Senior Managers for Manufacturing and Quality Assurance
• FDA consultants
• Senior Operations and Finance Executives
• Public Relations Professionals
• Senior Executive Management
• Marketing

Course Director: CASPER E. ULDRIKS ‎

Casper (Cap) Uldriks 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. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.