FDA 483 - Vet Pharma Friesoythe GmbH - March 24, 2023

Vet Pharma Friesoythe GmbH was cited for significant deficiencies in aseptic processing, quality control, and complaint handling during an FDA inspection. Observations included poor aseptic techniques, inadequate environmental monitoring, insufficient cleaning procedures, and a failure to thoroughly investigate product defects like leaking bottles and particulate contamination. The report highlights repeat observations from previous inspections, indicating persistent issues with manufacturing controls and quality systems.