Catalent Indiana FDA-483 Out

FDA has released the form FDA-483 with eight observations from a 4/13-4/24 reinspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN. The specific observations were:

• failure to always include the conclusions and follow-up in written records of investigations into the failure of a batch or any of its components to meet specifications ;
• failure to establish control procedures which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
• failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic and sterilization processes;
• failure to base the number of containers and amount of material taken from each container on appropriate criteria;
• aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
• failure to have in writing and fully follow the responsibilities and procedures applicable to the quality unit;
• failure of master production and control records to contain complete manufacturing and control instructions; and
• failure of equipment used in the manufacture, processing, packing, or holding of drug products to be of appropriate design to facilitate operations for its intended use.

The facility, which is now owned by Novo Nordisk, has been under FDA scrutiny following a 2025 Warning Letter that cited significant GMP violations after investigators found repeated failures to properly investigate contamination events and aseptic processing risks. The facility has a history of compliance troubles. Most recently, FDA assigned an “Official Action Indicated” classification to a July 2025 inspection (see story) that revealed significant GMP deficiencies. The serious compliance designation has delayed the approval and production timelines for drug products, including those from partner companies Regeneron and Scholar Rock, which are made at the plant.

The April reinspection documented findings that financial analysts grouped into three recurring themes: persistent contamination and control failures, inadequate contamination control and inspection validation, and systemic deficiencies in quality systems and investigation practices. The contamination problems at the Bloomington plant are not new — and that's precisely the concern. FDA previously cited recurring particulate contamination, including the presence of mammalian hair, alongside repeated aseptic processing failures and water leakage events that persisted despite prior corrective actions and root-cause investigations, according to the analysts.