# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - March 19, 2024

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/e6b0aa44-ffb1-43ad-8bfa-ed4a14f0dd72

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) on March 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
- Inspection Date: 2024-03-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Vetter Pharma-Fertigung GmbH & Co. KG, a sterile drug product manufacturer in Ravensburg, Germany, was cited for significant deficiencies in its quality systems. Observations included inadequate procedures to prevent microbiological contamination, a lack of identity testing for labeled drug products, a deficient visual inspection program, and incomplete written procedures for manufacturing and testing. These issues indicate a need for improved controls over sterile manufacturing, product quality, and documentation practices.

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Company: https://www.keypedia.com/companies/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/d0287c3d-c544-40de-aece-ba713025286c

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd