Sun Pharma Canada Inc. — Health Canada Inspection Findings

The company's oversight of the contracted party was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The recorded information or details were inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

Measures to ensure the compliance of the contracted test laboratories were inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

The implementation of a self-inspection program was inadequate.