FDA 483 - Vet Pharma Friesoythe GmbH - February 04, 2025

Vet Pharma Friesoythe GmbH, a finished animal drug manufacturer in Friesoythe, Germany, was cited for three significant issues during an FDA inspection. Observations included inadequate validation of sterile drug product manufacturing processes, deficiencies in cleaning and disinfection procedures for processing areas, and insufficient laboratory records to ensure the accuracy and reliability of sterility test methods. These findings indicate a moderate level of severity regarding quality control and sterile manufacturing practices.