FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)

An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, from July 11-17, 2019, identified significant issues with aseptic behavior and adherence to standard operating procedures. Personnel were observed not following controlled movement protocols and performing operations directly over unprotected drug product vials in Grade A/B cleanrooms. These observations indicate a failure to maintain adequate aseptic conditions during pharmaceutical production.