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# Catalent Indiana FDA-483
- URL: https://www.fdaweb.com/catalent-indiana-fda-483/
- Published: 2024-03-27T12:00:00.000Z
- Updated: 2026-09-14T14:26:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156643

FDA has released the form [FDA-483](https://www.fda.gov/media/177229/download?ref=fdaweb.com) issued following a 10/31-11/15/2023 inspection at the Catalent Indiana drug manufacturing facility in Bloomington, IN. The inspection observations were:

- failing to fully follow the responsibilities and procedures applicable to the quality control unit;
- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to include adequate validation of the aseptic process in procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile;
- failing to establish control procedures that 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;
- failing to have laboratory controls include the establishment of scientifically sound and appropriate test procedures to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.