FDA WARNING_LETTER - Quali Controle - September 15, 2017

The FDA issued a Warning Letter to Quali-Controle & Quali-Controle C.E.BAC following a September 2017 inspection, citing significant violations of CGMP regulations for testing finished pharmaceuticals, rendering their drugs adulterated.

Key violations include: 1. **Failure to validate test methods (21 CFR 211.165(e))**: The firm used unvalidated non-compendial test methods for drug product analysis. Their response, which included adding a disclaimer to Certificates of Analysis, was deemed inadequate as it did not address reviewing past analyses or ensuring future method validation/transfer. The FDA requires a protocol and timelines for method validation/transfer, an assessment of the impact of unvalidated methods on U.S. market products, and a procedure for future method validation. 2. **Failure to investigate OOS results (21 CFR 211.192)**: The firm invalidated out-of-specification (OOS) results without scientific justification or a documented investigation. Their claim of dirty glassware as a root cause lacked scientific basis and adequate CAPA. The FDA requires a retrospective review of OOS results, a report of findings, a CAPA plan, and a revised OOS investigation procedure. 3. **Failure to follow Quality Agreement**: The firm did not adhere to their quality agreement with a customer regarding the use of the United States Pharmacopeia for drug component testing and failed