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 four observations during an FDA inspection. The observations primarily concern deficiencies in preventing microbiological contamination, inadequate identity testing procedures for labeled products, a deficient visual inspection program, and insufficient written procedures for manufacturing and testing. These issues indicate a need for improved controls in aseptic processing, quality control, and documentation practices.