FDA 483 - Halo Pharmaceutical Canada Inc - September 28, 2023

An FDA inspection of Halo Pharmaceutical Canada Inc, a contract drug manufacturer in Mirabel, Quebec, revealed significant deficiencies in quality control and manufacturing processes. Observations included failures to thoroughly investigate out-of-specification results for drug product impurities, incomplete cleaning validations for manufacturing equipment, and inadequately qualified production equipment. These issues indicate a lack of robust control over critical aspects of drug product manufacturing.