FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - May 13, 2026

An FDA inspection of Vetter Pharma Fertigung GmbH & Co. KG, a licensed biological manufacturer in Ravensburg, Germany, identified significant deficiencies in batch production and control records, as well as laboratory records. The firm failed to maintain complete information for batch production, including the disposition status of unreconciled syringes, and lacked proper documentation in laboratory records as specified by their own SOPs. These issues indicate a lack of adequate control over manufacturing and quality processes.