FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - April 24, 2024
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An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, revealed significant deficiencies in the manufacturing of sterile drug products. The firm failed to establish and follow procedures to prevent microbiological contamination, exhibited a deficient visual inspection program unable to remove defects, and had inadequate environmental monitoring in aseptic processing areas. These issues indicate a lack of control over critical processes, posing a risk to product quality and sterility.
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