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Talk to a SpecialistTalk to a SpecialistExcelvision Fareva's manufacturing facility in France was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of sterile drug products. FDA investigators found that the company failed to conduct thorough investigations of batch discrepancies and customer complaints, particularly regarding contamination issues such as mold, black specks, and discoloration reported between January 2023 and November 2024. The firm did not adequately determine root causes, evaluate affected product samples, or implement sufficient corrective and preventive actions (CAPAs) for these quality failures. As a result, the company's drug products were determined to be adulterated under the Federal Food, Drug, and Cosmetic Act.