FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) - April 11, 2019

An FDA inspection of Vetter Pharma Fertigung GmbH & Co. KG in Ravensburg, Germany, revealed significant deficiencies in quality control and laboratory operations. The firm failed to thoroughly investigate discrepancies, ensure timely completion of investigations, and maintain adequate control over sample analysis. Additionally, the quality control unit lacked proper written procedures and agreements with contract laboratories.