The Infamous Form FDA 483: How you respond can make or break you
Duration: 60 Minutes
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The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations.
05/09/2013 11:19 AMTraining Topic: The Infamous Form FDA 483: How you respond can make or break youInstructor: Casper E Uldriks
The issuance of a 483 by the CSO at the conclusion of an inspection will be discussed with the establishment's management and put them on notice that the nonconformities warrant correction and that a failure to do so may result in further action by the FDA, such as civil money penalties, seizure, injunction, and/or prosecution. Firm's are well advised to take the warning seriously.
Prior to an inspection, the CSO will review prior 483s issued to the establishment and the responses previously made by the firm concerning promised corrections. You will be held accountable for your prior response. What you promise and what you do, or don't do, become critical factors in the FDA's assessment of a firm's capacity to operate in compliance with the FDA's applicable requirements. A failure to establish and implement a corrective action to prevent prior deficiencies reflects poorly on the firm's management. The FDA will hold the firm's management accountable for its failure to adequately correct its regulatory problems. In some cases, the FDA will hold senior 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 difference. It creates a body of proof that may set the basis for legal action by the FDA.
Objectives of the Presentation:
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
Plan for the wake of problems generated by a 483
Learn how to restore, or destroy, your regulatory profile with the FDA
Who can Benefit:
Senior Operations and Finance Executives
Regulatory Affairs Professionals
In-house Legal Counsel
Senior Managers for Manufacturing and Quality Assurance