FDA 483 - Excelvision - July 07, 2023

An FDA inspection of Excelvision, a drug manufacturer in Annonay, France, from June 29 to July 7, 2023, revealed significant deficiencies in aseptic processing. The firm's investigations into unexplained discrepancies and mold contamination were inadequate, and its cleaning, disinfection, and environmental monitoring systems were found to be deficient. These issues indicate a high risk of microbiological contamination for sterile drug products.