# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - November 02, 2026

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/58a47cca-e9e3-4e53-8f4a-ae3cc5f6d64b

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG on November 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetter Pharma Fertigung GmbH & Co. KG
- Inspection Date: 2026-11-02
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, revealed two significant observations. The firm failed to thoroughly review unexplained discrepancies, specifically regarding defects found during visual inspection of reference or retention samples. Additionally, the procedure for identifying in-progress drug product samples was not clearly described in their SOP.

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