FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - March 19, 2024

Vetter Pharma-Fertigung GmbH & Co. KG, a sterile drug product manufacturer in Ravensburg, Germany, was cited for significant deficiencies in its quality systems. Observations included inadequate procedures to prevent microbiological contamination, a lack of identity testing for labeled drug products, a deficient visual inspection program, and incomplete written procedures for manufacturing and testing. These issues indicate a need for improved controls over sterile manufacturing, product quality, and documentation practices.