# FDA 483 - Zoetis Belgium S.A. - November 22, 2022

Source: https://www.keypedia.com/records/483/zoetis-belgium-sa/03eafc64-063e-413b-bb2b-3741149a2127

> FDA 483 for Zoetis Belgium S.A. on November 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoetis Belgium S.A.
- Inspection Date: 2022-11-22
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Zoetis Belgium S.A., a sterile drug products manufacturer in Louvain-la-Neuve, Belgium, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed failures in preventing microbiological contamination, adhering to stability testing programs, thoroughly investigating customer complaints, and establishing adequate production controls for visual particulate inspection. These issues indicate a lack of robust quality assurance for sterile drug products.

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [James K. Rice](https://www.keypedia.com/people/james-k-rice/b8d40430-5ff3-478c-a141-e83eefaac022)

Company: https://www.keypedia.com/companies/zoetis-belgium-sa/b21b52a1-7a14-464f-aab2-c3d558f53879

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4