FDA 483 - Catalent Massachusetts, LLC - April 07, 2026

During an FDA inspection, Catalent Massachusetts, LLC, a manufacturer in Chelsea, MA, was cited for significant deviations from written production and process control procedures. The firm failed to adhere to its aseptic sampling technique for bulk powder and violated its data integrity policy by allowing the use of generic administrator accounts for testing. These findings indicate a lack of adherence to established internal controls critical for product quality and data reliability.