483
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) – FDA 483, Aug 26, 2022
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
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ID · b7363b3b-9f74-4b28-beed-5e9a49563aa1
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