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# UCB Farchim FDA-483 Released
- URL: https://www.fdaweb.com/ucb-farchim-fda-483-released/
- Published: 2023-10-24T12:00:00.000Z
- Updated: 2026-09-14T14:14:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155628

FDA has released the form FDA-483 issued following a 6/26-7/4 inspection at UCB Farchim SA, a drug substance and bulk drug product manufacturer in Bulle, Fribourg, Switzerland. The four inspection observations were:

- quality unit oversight over quality control operations is deficient, including laboratory and production electronic systems and data review;
- appropriate controls are not exercised over computers or related systems to assure that changes in laboratory control records or other records are instituted only by authorized personnel;
- the accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented; and
- written procedures that describe in sufficient detail the handling of components are lacking.