FDA 483 - Intervet International GmbH - April 28, 2023

An FDA inspection of Intervet International GmbH, a manufacturer in Unterschleissheim, Bavaria, identified two significant observations. The firm was cited for inadequate control over access to label and labeling material storage, including unlocked cages and unattended label rolls. Additionally, the inspection found that the accuracy, sensitivity, specificity, and reproducibility of test methods were not established and documented, specifically regarding filtration test samples and stability chamber validation.