FDA 483 - PF Soins de Sante SRI - October 27, 2023

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.