# FDA 483 - Catalent Belgium SA - July 07, 2017

Source: https://www.keypedia.com/records/483/catalent-belgium-sa/53e42813-d6b8-477e-883e-6b1c94f2e69f

> FDA 483 for Catalent Belgium SA on July 07, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Belgium SA
- Inspection Date: 2017-07-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Catalent Belgium, SA in Brussels, Belgium, revealed several significant deficiencies in their manufacturing and quality control processes. The firm failed to thoroughly investigate discrepancies and out-of-specification results, and lacked adequate validation for sterilization processes. Other issues included unauthorized access to labeling materials, insufficient environmental monitoring, and poor equipment maintenance, indicating a need for improved quality systems.

## Related Documents

- [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 - 2026-02-07](https://www.keypedia.com/records/483/catalent-belgium-sa/fa83cb21-e34f-4eac-9039-a029ee5ef976)
- [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

- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)
- [Gena Arcy, CSO](https://www.keypedia.com/people/gena-arcy-cso/5e73742f-22df-4750-82a8-430f86192916)

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