483
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - August 26, 2022
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.
Record Details
An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, for drug product manufacture revealed significant issues. The firm was cited for deficient written procedures for production and process control, including improper RABS setup and inadequate deviation investigations for HEPA filter failures. Additionally, equipment maintenance was found to be inadequate, and standard operating procedures for documentation practices were not followed.
- Inspection Date
- August 26, 2022
- Product Type
- Drugs
Open in Dashboard
ID · b7363b3b-9f74-4b28-beed-5e9a49563aa1