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# 3 Observations in UCB Pharma FDA-483
- URL: https://www.fdaweb.com/3-observations-in-ucb-pharma-fda-483/
- Published: 2023-05-26T12:00:00.000Z
- Updated: 2026-09-14T18:34:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154553

FDA has released the form FDA-483 issued following a 4/17-4/21 inspection at the UCB Pharma drug manufacturing facility in Braine-l’Alleud, Belgium. The three inspection observations were:

- failure of the quality unit to establish adequate document control of the forms used for good manufacturing practice activities;
- inadequate environmental and personnel monitoring in classified areas; and
- inadequate procedures to describe the handling and rejection of in-process materials.