483
PF Soins de Sante SRIPF Soins de Sante SRI – FDA 483, Oct 27, 2023
Record Details
An FDA inspection of PF Consumer Healthcare Canada ULC in Saint-Laurent, a drug manufacturer, revealed significant deficiencies in its quality control unit. Observations included contaminated manufacturing environments with rust, mold, and dust in ceiling grids, potentially compromising product safety. Additionally, the firm failed to thoroughly investigate multiple customer complaints regarding product quality and adverse events, as well as an out-of-specification result.
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ID · 6558c130-868a-4b26-9c23-4431f8e69d59
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