Vetter Pharma Fertigung GmbH & Co. KG

FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG

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Record Details

The FDA inspection of Vetter Pharma-Fertigung GmbH & Co. kg in Ravensburg, Germany, revealed significant deficiencies across multiple quality control areas. Observations included inadequate visual inspection and sampling of incoming materials, insufficient investigations into numerous product delivery and safety device complaints, and a lack of Quality Unit oversight for aseptic media fills. The firm also failed to conduct product impact assessments for microbial excursions, and showed deficiencies in media growth promotion studies, environmental monitoring, and water system trending.

Company: Vetter Pharma Fertigung GmbH & Co. KG
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Omotunde Osunsanmi (issuing_officer)

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ID · 78e584ab-e89d-4a9b-b6ab-fae856095835