483
Vetter Pharma Fertigung GmbH & Co. KGVetter Pharma Fertigung GmbH & Co. KG – FDA 483, Nov 2, 2017
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.
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ID · 58a47cca-e9e3-4e53-8f4a-ae3cc5f6d64b
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