Vetter Pharma Fertigung GmbH & Co. KGNovember 2, 2026

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

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Record Details

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.

Company: Vetter Pharma Fertigung GmbH & Co. KG
Inspection Date: November 2, 2026
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Mihaly S. Ligmond (CSO)

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ID · 58a47cca-e9e3-4e53-8f4a-ae3cc5f6d64b