FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
Discuss this record with AI
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.
An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, from July 11-17, 2019, identified significant issues with aseptic behavior and adherence to standard operating procedures. Personnel were observed not following controlled movement protocols and performing operations directly over unprotected drug product vials in Grade A/B cleanrooms. These observations indicate a failure to maintain adequate aseptic conditions during pharmaceutical production.
- Product Type
- Drugs
ID · d970a219-8649-4511-b4c9-de455872dea0