FDA 483 - Dominion Veterinary Laboratories Ltd. - September 21, 2023

Dominion Veterinary Laboratories Ltd. in Winnipeg, Manitoba, an animal drug manufacturer, received a Form 483 with five observations during an FDA inspection. The firm was cited for deficiencies in component and microbiology testing, inadequate quality control procedures for change management, insufficient in-process controls for product homogeneity, and a lack of appropriate computer system access controls for master records. These findings indicate significant concerns regarding the firm's adherence to good manufacturing practices for animal drugs.