FDA 483 - Vetio Animal Health - August 18, 2023

An FDA inspection of Vetio Animal Health in Saint-Laurent, a drug manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate computer system controls leading to unauthorized data modifications, a failure to properly investigate and classify numerous discrepancies, and a lack of timely calibration for critical manufacturing and QC equipment. Additionally, the firm failed to follow written procedures for master production records and ensure contemporaneous record-keeping, and drug products were not stored under appropriate temperature and humidity controls with real-time monitoring.