FDA 483 - Provepharm Life Solutions - April 19, 2024

PROV'PHARM Life Solutions, an API manufacturer in Marseille, France, was cited for significant deficiencies across its quality system, laboratory controls, and facility and equipment. Key issues include inadequate investigations into out-of-specification results, widespread data integrity concerns with manufacturing records and laboratory systems, and a complete lack of validated cleaning procedures. These observations indicate a systemic failure to adhere to cGMP requirements.