FDA 483 - Pharmgate Inc. - September 04, 2025

Pharmgate Inc. in Omaha, NE, an animal drug and medicated article manufacturer, was cited for significant deficiencies in its quality control unit's oversight of manufacturing operations. The firm's Quality Unit failed to ensure accuracy in critical process parameters, leading to repeated errors in weight calculations, lot numbers, and expiration dates despite implemented corrective actions. These issues highlight a lack of effective review authority and verification processes.