FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - August 19, 2022

An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, identified two significant observations related to drug product manufacturing. The firm was cited for inadequate maintenance of equipment and facilities, including cracks in cleanroom enclosures and unsealed interfaces. Additionally, deficiencies were noted in written procedures for production and process control, specifically concerning RABS sanitization and the investigation of non-integral HEPA filters.