# FDA 483 - Catalent Belgium SA - February 07, 2026

Source: https://www.keypedia.com/records/483/catalent-belgium-sa/fa83cb21-e34f-4eac-9039-a029ee5ef976

> FDA 483 for Catalent Belgium SA on February 07, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Belgium SA
- Inspection Date: 2026-02-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Catalent Belgium S.A. in Brussels was inspected and cited for significant deficiencies across its drug product manufacturing operations. The inspection revealed failures in process validation, quality control procedures, adherence to written production controls, batch record completeness, and labeling accountability. These issues indicate a lack of robust control over critical manufacturing and quality systems.

## Related Documents

- [483 - 2017-07-07](https://www.keypedia.com/records/483/catalent-belgium-sa/53e42813-d6b8-477e-883e-6b1c94f2e69f)
- [483 - 2017-07-07](https://www.keypedia.com/records/483/catalent-belgium-sa/7ec032fb-d69c-40c5-b216-56d25037461d)
- [EIR - 2022-08-19](https://www.keypedia.com/records/eir/catalent-belgium-sa/885f1132-6075-4922-909a-a5d88ab0e69d)
- [483 - 2022-08-19](https://www.keypedia.com/records/483/catalent-belgium-sa/a5641d00-652f-47a6-a7f2-a1b291a6e2c8)
- [483 - 2016-11-25](https://www.keypedia.com/records/483/catalent-belgium-sa/1c9f4538-4467-45ac-b533-8f0bcb3d040a)

## Related Officers

- [Jessica Hankins](https://www.keypedia.com/people/jessica-hankins/199a210e-6fa6-4d96-928d-4eee36658454)
- [FDA Biologics Investigator](https://www.keypedia.com/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)

Company: https://www.keypedia.com/companies/catalent-belgium-sa/f48653bf-84a2-4aeb-bdc3-ca2d0cc4fdf2

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd