FDA 483 - UCB Farchim SA - July 04, 2023

UCB Farchim SA, a drug substance and bulk drug product manufacturer in Bulle, Switzerland, received a Form 483 with significant findings. The inspection revealed critical deficiencies in quality unit oversight, particularly concerning electronic data integrity, control over computerized systems, and the validation of test methods. Additionally, the firm lacked adequate written procedures for handling components during material receipt.