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FDA Warning Letter: Should Internal Assessment Information be Part of the Corrective Action Response to the FDA?

It is very important to do your own assessment beyond the notice of violation or Form 483 (483) to determine if there are any broader or systemic issues. If you address only the issues outlined in the Establishment Inspection Report (EIR), 483, or notice of violation it is possible that the Food and Drug Administration (FDA) or another regulatory body will find other issues that are still existent in your system. This key milestone should be a precursor to completing the remediation plan. The remediation plan should include all of the commitments and responses to the FDA as well as items identified through the internal assessment.

Including the internal assessment in your response shows that you are taking the situation seriously and that you have done all of your due diligence. It demonstrates that you did not just look myopically at the issues raised by the FDA and that you have done a very thorough root cause analysis.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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