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

During an inspection conducted from February 10-14, 2020, the U.S. Food and Drug Administration (FDA) identified significant deficiencies at Intervet Mexico S.A. de C. V., an Active Pharmaceutical Ingredient (API) manufacturer. The inspection revealed multiple violations related to quality control and manufacturing practices, primarily concerning particulate contamination in manufactured products. A key issue was the company's failure to thoroughly investigate batch failures, specifically those exhibiting atypical color or particulate matter. Investigations were incomplete, and many affected product lots were released to the market without adequate assessment of particulate content. Furthermore, critical processing equipment was not properly qualified for its intended use, contributing to contamination. The company's Quality Unit also failed to adhere to its own written procedures for handling deviations and establishing effective corrective and preventive actions, particularly concerning recurring particulate contamination originating from raw material suppliers. Despite long-standing awareness of this issue since 2016, Intervet Mexico did not effectively manage supplier quality, nor did its supplier certification program ensure compliance. Additionally, cleaning and maintenance procedures for essential manufacturing equipment were found to be deficient. These observations highlight a systemic breakdown in ensuring product quality and safety, requiring comprehensive corrective actions from Intervet Mexico to align with good manufacturing practices.