5 Observations on Excelvision FDA-483

FDA has released the form FDA-483 issued following an 11/12-11/19/2024 inspection at Excelvision, a drug manufacturer in Annonay, Ardèche, France. The five inspection observations were:

• failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up;
• failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic process;
• aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
• aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions; and
• failure of laboratory records to include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.