# FDA 483 - UCB Pharma S.A. - April 21, 2023

Source: https://www.keypedia.com/records/483/ucb-pharma-sa/faf15e0c-4ee4-4868-84c5-48cd719f4855

> FDA 483 for UCB Pharma S.A. on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCB Pharma S.A.
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: UCB Pharma SA in Braine, Belgium, was inspected for drug product manufacturing, revealing significant deficiencies. The firm failed to establish adequate document control for GMP activities, including the use of uncontrolled forms and concerns about shredded quality documents. Additionally, environmental and personnel monitoring in classified areas were found to be inadequate, and procedures for handling and rejecting in-process materials were insufficient.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/ucb-pharma-sa/7634bf8a-098c-4f65-869f-8b8dc49bf228)
- [483 - 2022-02-04](https://www.keypedia.com/records/483/ucb-pharma-sa/4d10a705-f62a-4e4d-a1a3-bc75539da471)
- [EIR - 2022-02-04](https://www.keypedia.com/records/eir/ucb-pharma-sa/c0412e1a-bd81-4e61-8d2c-6bc873ddb1ac)
- [483 - 2022-02-04](https://www.keypedia.com/records/483/ucb-pharma-sa/6036226d-2920-43af-9bd3-61847498eee7)
- [EIR - 2023-04-21](https://www.keypedia.com/records/eir/ucb-pharma-sa/0a4d5150-1f3d-4902-a9e3-98e6c80b367f)

## Related Officers

- [Harriet M. Trainor](https://www.keypedia.com/people/harriet-m-trainor/a8d187ec-dd59-48e2-801e-c1470e545219)
- [Consumer Safety Officer at FDA](https://www.keypedia.com/people/alice-s-tsao/b6d72ceb-de7c-413d-b104-cac3b075c170)
- [Madhusini Dharmasena](https://www.keypedia.com/people/madhusini-dharmasena/f78bfd9f-9611-435e-a21c-3db2d51f0f5b)

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

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