FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - April 24, 2024

An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, a sterile drug product manufacturer, revealed significant deficiencies. Observations included failures to prevent microbiological contamination during aseptic filling, an inadequate visual inspection program that repeatedly failed to remove defective products, and deficient environmental monitoring in aseptic processing areas. These issues raise concerns about the sterility assurance and quality control of their sterile drug products.