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

An FDA inspection of Vetter PharmaFertigung GmbH&Co KG in Ravensburg, Germany, a drug warehouse and sterile drug product visual inspection site, revealed multiple significant deficiencies. Observations included inadequate quality control unit procedures, incomplete drug complaint investigations, insufficient GMP training, and lacking written procedures for sampling and equipment qualification. Additionally, issues were noted with uncontrolled access to labeling materials and unsanitary conditions in storage areas.