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# Catalent Brussels Plant Inspected Again
- URL: https://www.fdaweb.com/catalent-brussels-plant-inspected-again/
- Published: 2022-10-24T12:00:00.000Z
- Updated: 2026-09-14T18:04:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153040

For the second time in a year, FDA has inspected contract manufacturer Catalent’s Brussels, Belgium, facility, this time resulting in a nine-item Form FDA-483\. The September inspection occurred simultaneously with an inspection at the firm’s Bloomington, IN facility that performs fill operations on Moderna’s Covid-19 Bivalent booster vaccine. That inspection led to a 12-item Form FDA-483 over GMP concerns ([see earlier story](https://www.fdaweb.com/catalent-hit-with-12-item-483-on-moderna-vaccine/)).

The Belgium inspection cited the facility’s aseptic processing areas as being deficient, and failing to thoroughly review any unexplained discrepancy. It also cited its control procedures for manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product, among other issues, according to the [FDA-483](https://www.fda.gov/media/162470/download?ref=fdaweb.com).

A year ago, the same Brussels plant was inspected by FDA ([see story](https://www.fdaweb.com/catalent-belgium-fda-483/)). The seven inspection observations were:

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch was already distributed;
- failing to establish written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to adequately establish validations designed to prevent microbial contamination of a drug product purporting to be sterile;
- failing to have an adequate written procedure designed to prevent contamination of products during aseptic processing;
- failing to adequately maintain or appropriately design equipment and facilities used in the manufacture of drug products to facilitate operations for their intended use;
- failing to adequately validate the laboratory analytical method for endotoxin; and
- standard operating procedures are not followed or are deficient.