FDA 483 Responses—Compliance Considerations | IVT


The following key points are discussed in this article:

  • US Food and Drug Administration current good manufacturing practices (CGMPs) provide fundamental requirements for pharmaceutical manufacturing
  • The FDA 483 is the official recording of FDA investigator observations from an FDA inspection
  • An inadequate inspection response is the primary reason for warning letters being issued in 2008
  • FDA’s Anita Richardson (Center for Biologics Evaluation and Research) discussed topics associated with writing an effective Form 483 response at the 5th Annual FDA and the Changing Paradigm for HCT/P Regulation conference in January 2009
  • Responses to FDA 483s are not legally required; however, responses are strongly recommended
  • Responses may mitigate an FDA compliance decision for further action
  • Responses demonstrate understanding and acknowledgement of the observations
  • Responses demonstrate a commitment to correct or voluntarily comply with corrective actions
  • Responses establish credibility with FDA
  • Failure to respond, inadequate responses, or failure to adhere to promised corrective actions make a firm susceptible to aggressive regulatory or legal actions by FDA such as product seizure, legal injunction, and other actions
  • After an inspection, an action plan should be quickly developed to address each observation
  • Effective responses should include a commitment statement from senior leadership, should address each observation separately, should provide corrective action accomplished planned, and should be specific, complete, realistic, and deliver on commitments
  • Effective responses must be timely, include timeframes for correction, verification methods, monitoring of corrections, and supporting documentation
  • FDA has implemented a Warning Letter Close-out Program
  • The Enforcement Story, Fiscal Year 2008 summarizes FDA compliance activities during 2008 and provides useful statistics
  • Firms should be very familiar with their incoming materials and product supply chain
  • Firms should fully understand the interactions of the processes and systems that impact quality, safety, and effectiveness of their products
  • As part of responding to FDA 483 observations, firms should also assess their general internal compliance programs—Why were 483 deficiencies not detected internally?
  • FDA 483 observations may be caused or intensified by inadequate audit management (i.e., logistics, timelines of responses, documentation retrieval, etc.) as well as soft “people” skills.

Download "FDA 483 Responses—Compliance Considerations"

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