FDA 483 - Halo Pharmaceutical Canada Inc - November 14, 2014

Halo Pharmaceutical Canada Inc. in Mirabel, Quebec, a contract drug manufacturer, was cited for multiple deficiencies during an FDA inspection from November 10-14, 2014. Key issues included inadequate laboratory controls for test procedures, incomplete out-of-specification investigations, and failures in labeling inspection, change control, and material storage procedures. These observations indicate significant concerns with quality control and adherence to established procedures.