FDA 483 - Intervet Mexico S.A. de C.V. - MSD Animal Health - February 14, 2020

An FDA inspection of Intervet Mexico S.A. de C. V. in Ecatepec de Morelos revealed significant quality control deficiencies. The firm failed to thoroughly investigate batch failures related to particulate contamination, did not qualify critical manufacturing equipment, and did not adhere to its own deviation handling procedures. These issues led to the release of numerous drug product lots without adequate assessment of their quality and safety.