Vetter Pharma Fertigung GmbH & Co. KG – FDA EIR, Nov 10, 2017

An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, was conducted from November 2-10, 2017. This Level 1 GMP inspection focused on commercial biologic drug products, with the Center for Biologics Evaluation and Research (CBER) as the lead center, alongside other US products manufactured at the site. The inspection covered the Quality System, Facilities and Equipment System, Production System, and Laboratory Control System. As a result, a Form FDA 483 was issued with two observations. The first observation cited a failure to thoroughly review unexplained discrepancies, specifically the lack of a required investigation if defects were detected during the visual inspection of reference or retention samples, provided reject limits were not exceeded and no atypical or unknown defects were found. The second observation noted that drug product samples were not properly identified, as the procedure for Quality Control Chemical Analysis Laboratory analysts to identify in-progress samples lacking prior labeling was deficient. Management was informed that a written response within 15 working days was required for consideration by the Agency before potential enforcement actions, such as Warning Letters or Import Alerts. The firm provided a draft revised Standard Operating Procedure as a corrective action for the second observation.