FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - August 26, 2022

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.