Vetter Pharma Fertigung GmbH & Co. KG – FDA 483
The FDA inspection of Vetter Pharma-Fertigung GmbH & Co. kg in Ravensburg, Germany, revealed significant deficiencies across multiple quality control areas. Observations included inadequate visual inspection and sampling of incoming materials, insufficient investigations into numerous product delivery and safety device complaints, and a lack of Quality Unit oversight for aseptic media fills. The firm also failed to conduct product impact assessments for microbial excursions, and showed deficiencies in media growth promotion studies, environmental monitoring, and water system trending.
- Product type
- drugs
ID · 78e584ab-e89d-4a9b-b6ab-fae856095835
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.