FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - January 09, 2017

Vetter Pharma Fertigung Gmbh & Co. KG. in Ravensburg, Germany, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included incomplete complaint investigations, non-standardized sampling procedures, lack of identity testing for incoming APIs, and inadequate audit trails for computer systems. Additionally, the firm lacked assurance of ISO-5 classification maintenance during sterility testing.