FDA EIR - UCB Farchim SA - July 04, 2023

An FDA comprehensive cGMP inspection of UCB Farchim SA, a foreign non-sterile human active pharmaceutical ingredient (API) and finished drug manufacturer located in Bulle, Switzerland, was conducted from June 26 to July 4, 2023. This inspection, which covered Quality, Production, Facilities & Equipment, Materials, and Laboratory Control Systems, aimed to assess compliance with Good Manufacturing Practice (GMP) regulations for drug products shipped to the U.S. market, including those outlined in compliance programs 7356.002, 7356.002F, 7356.002M, and ICH Q7 guidance. The inspection resulted in four significant observations documented in an FDA-483. Key issues included deficient quality unit oversight over quality control operations, particularly concerning electronic systems and data review. Furthermore, the company failed to implement appropriate controls over computer systems to ensure only authorized personnel could modify laboratory records. The inspection also noted a lack of established and documented accuracy, sensitivity, specificity, and reproducibility for test methods, and the absence of detailed written procedures for handling components. UCB Farchim SA committed to evaluating all observations and providing an initial written response within 15 business days. The inspection was classified as Voluntary Action Indicated (VAI), signifying that while objectionable conditions were found, the firm's voluntary corrective actions are expected.