Vetter Pharma Fertigung GmbH & Co. KG – FDA 483, May 13, 2019
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.
ID · 558703ee-5908-4eb9-b88e-53f9d6102875
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.