FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

French API Maker Written Up for Quality Unit Failures

Aug. 30, 2019

The FDA hit a French manufacturer of APIs and intermediates with a Form 483 for quality violations at its facility in Limay, west of Paris.

The agency flagged inadequate cleaning at the PCAS facility that put the quality of the firm’s API and intermediate products at risk. Specifically, the company shared equipment for manufacturing the two types of products but lacked proper procedures to prevent cross-contamination.

The quality unit also failed to properly review and approve quality-related documents, including a CAPA, which was opened and approved for closure by the same individual. Similarly, a quality control validation report was written and approved by the same quality control employee. The firm also neglected to perform failure investigations for “non-critical” manufacturing deviations.

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