FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - August 19, 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.
An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, identified two significant observations related to drug product manufacturing. The firm was cited for inadequate maintenance of equipment and facilities, including cracks in cleanroom enclosures and unsealed interfaces. Additionally, deficiencies were noted in written procedures for production and process control, specifically concerning RABS sanitization and the investigation of non-integral HEPA filters.
ID · 8e10db45-a299-4f5e-905e-47759b69f316