FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - April 26, 2016

An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, revealed significant deficiencies in their manufacturing and quality control processes. The firm failed to justify deviations from production procedures, conducted inadequate investigations into discrepancies including glass particles in sterile products, and lacked written procedures for quality control unit responsibilities. Additionally, operators did not follow or properly document production procedures, complaint handling was deficient, and equipment calibration was not performed according to a written program.