FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - September 20, 2024

An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG, a drug product manufacturer, revealed significant deficiencies in aseptic processing and quality assurance. Observations included inadequate procedures to prevent microbiological contamination during sterile drug product manufacturing and a failure by Quality Assurance to provide clear conclusions on process validation data. These issues indicate a lack of control over critical manufacturing and quality systems.