FDA 483 - Bimeda MTC Animal Health Inc. - September 22, 2023

Bimeda MTC Animal Health Inc., a veterinary drug manufacturer in Cambridge, Ontario, Canada, received a Form 483 with two observations. The inspection revealed significant issues with quality control investigations, including inadequate review of environmental excursions and process interventions. Additionally, the firm failed to properly calibrate and maintain laboratory instruments, lacking performance qualifications, routine checks, and comprehensive maintenance records for critical equipment like HPLC and GC systems.