# FDA 483 - UCB Pharma S.A. - February 04, 2022

Source: https://www.globalkeysolutions.net/records/483/ucb-pharma-sa/6036226d-2920-43af-9bd3-61847498eee7

> FDA 483 for UCB Pharma S.A. on February 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCB Pharma S.A.
- Inspection Date: 2022-02-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of UCB Pharma SA in Braine-l'Alleud, Belgium, identified significant deficiencies in process controls for drug product manufacturing, including issues with aseptic processing, visual inspection, and equipment cleaning. The firm also failed to ensure adequate utility design and facility maintenance. These observations indicate a lack of control over critical aspects of drug production and facility upkeep, potentially impacting product quality and sterility.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/ucb-pharma-sa/6a03badf-6619-4125-b598-85ceebcc8c50

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