# FDA 483 - Catalent Belgium SA - October 26, 2021

Source: https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/5f428877-75e7-4d0c-a321-d784b42dae0b

> FDA 483 for Catalent Belgium SA on October 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Belgium SA
- Inspection Date: 2021-10-26
- 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 thoroughly investigating discrepancies like HEPA filter failures and environmental monitoring excursions, as well as inadequate process and cleaning validations for sterile products. Additionally, issues with equipment maintenance, facility design, and adherence to standard operating procedures were noted, indicating a broad lack of control over critical manufacturing processes.

## Related Documents

- [483 - 2017-07-07](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/53e42813-d6b8-477e-883e-6b1c94f2e69f)
- [483 - 2017-07-07](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/7ec032fb-d69c-40c5-b216-56d25037461d)
- [EIR - 2022-08-19](https://www.globalkeysolutions.net/records/eir/catalent-belgium-sa/885f1132-6075-4922-909a-a5d88ab0e69d)
- [483 - 2026-02-07](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/fa83cb21-e34f-4eac-9039-a029ee5ef976)
- [483 - 2022-08-19](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/a5641d00-652f-47a6-a7f2-a1b291a6e2c8)

## Related Officers

- [Lindsey Brown](https://www.globalkeysolutions.net/people/lindsey-brown/ff47f714-146f-474e-a6b8-2cf14c67dd4f)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

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