FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - November 02, 2017

Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, received an FDA Form 483 citing multiple deficiencies during an inspection. Observations included inadequate procedures for preventing microbial contamination of sterile products and a failure to thoroughly review unexplained discrepancies, such as persistent microbial recovery and conflicting cleaning re-qualification results. Additionally, the firm was cited for prematurely releasing starting materials and for not restricting access to labeling storage areas to authorized personnel.