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FDA Warning Letter Response and Remediation


You’ve just been issued a Form 483 following FDA inspection of your operations. These reported observations must be taken seriously and promptly addressed—what are the next steps?

Following receipt of a 483, your organization is required to construct a response letter detailing a timeline and intended course of action to amend the deficiencies uncovered by the investigator. Your company has 15 business days from the formal date of issuance to respond to the 483. The FDA need not confirm your response, but you will find it prudent to contact the agency and confirm receipt.

Depending on the severity of the issue, the FDA may return for another inspection and if the timeline has not been met or deficiencies not remediated, another 483 will be issued. In fact, 98% of Form 483 issuances are followed by another 483—this cycle could continue for months, even years.

Warning Letter

If your 483 responses are deemed insufficient, your company has shown a pattern of unresponsiveness, or the violation poses a direct threat to patient life, you may receive a Warning Letter.  This indicates a significant breach of FDA regulations and must be addressed promptly. Response to a Warning Letter must include a point-by-point remediation plan for each problem noted by the investigator as well as preventive measures to avoid recurring issues. There is a grace period of several months to years for your company to correct the issues. Ultimately failing to demonstrate corrective action can escalate a Warning Letter to a Consent Decree—a legal agreement detailing the actions pledged by the company to remediate severe problem areas.

How can USDM help?

  • Responding to a warning letter or 483
    • Assisting in the response to technical inquiries.  Technical data can span from questions regarding particle size and morphology characteristics, microbiology, dissolution, stability, relative impurities, clinical and pre-clinical data to finished form product and have experienced professionals in scientific and other technical areas.
    • Remediation Activities
      • Building program and project plan to address resources needed and address gaps.
      • Issue recommendations on how to close gaps, engage management to ensure company-wide action
  • Preventive Measures:
    • Build Compliance Wellness into your product and business processes up front
    • Conduct a formal assessment to evaluate legacy software and discover gaps in validation
    • Review SOPs against regulations and industry best practices for streamlined compliance
  • Emerging companies:
    • In terms of growth, where do you want to be in five years?
    • Devise a roadmap to achieve compliance needs as you move forward