# UCB Pharma S.A. – FDA 483

Source: https://www.keypedia.com/records/483/ucb-pharma-sa/7634bf8a-098c-4f65-869f-8b8dc49bf228

> FDA 483 for UCB Pharma S.A. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCB Pharma S.A.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: UCB Pharma S.A. in Braine-l'Alleud, Belgium, was inspected and cited for multiple deficiencies related to quality control and manufacturing processes. Observations included releasing products without sufficient stability data, inadequate visual inspection procedures, lack of scientific basis for stability and complaint evaluations, and insufficient quality oversight for contract manufacturers. The inspection revealed significant concerns regarding product quality, data integrity, and complaint handling.

## Related Documents

- [483 - 2023-04-21](https://www.keypedia.com/records/483/ucb-pharma-sa/faf15e0c-4ee4-4868-84c5-48cd719f4855) — date: April 21, 2023
- [EIR - 2023-04-21](https://www.keypedia.com/records/eir/ucb-pharma-sa/0a4d5150-1f3d-4902-a9e3-98e6c80b367f) — date: April 21, 2023
- [EIR - 2022-02-04](https://www.keypedia.com/records/eir/ucb-pharma-sa/c0412e1a-bd81-4e61-8d2c-6bc873ddb1ac) — date: February 4, 2022
- [483 - 2022-02-04](https://www.keypedia.com/records/483/ucb-pharma-sa/6036226d-2920-43af-9bd3-61847498eee7) — date: February 4, 2022

## Related Officers

- [investigator](https://www.keypedia.com/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)
- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

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