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# Catalent Belgium FDA-483
- URL: https://www.fdaweb.com/catalent-belgium-fda-483/
- Published: 2022-01-18T12:00:00.000Z
- Updated: 2026-09-14T17:28:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150946

FDA has released the FDA-483 issued following a 10/18-10/26/21 inspection at the Catalent Belgium fill and finish drug manufacturing facility in Brussels, Belgium. 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.

An online *BioPress Insider* [post](https://bioprocessintl.com/bioprocess-insider/regulations/catalent-hit-with-fda-483-at-belgian-fill-and-finish-facility/?ref=fdaweb.com) says the Catalent facility is the contract development and manufacturing company’s flagship European syringe-filling facility, producing over 175 million units annually.

The post quotes a market analyst as saying the site is the primary fill/finish supplier for Novo Nordisk’s weight loss drug Wegovy (semaglutide).

The company announced 12/17/21 that a contract manufacturer filling syringes for Wegovy pens for the U.S. market had temporarily stopped deliveries and manufacturing following issues with Good Manufacturing Practices. As a consequence, Novo Nordisk said, it does not expect to be able to meet demand in the U.S. in the first half of 2022 and few new patients are expected to be able to initiate treatment.

The analyst said the facility has been issued 12 FDA-483s in the last decade across nine FDA inspection visits.