Neilmed Pharmaceuticals Inc — Health Canada Inspection Findings

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The master production documents were inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.

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

The implementation of a self-inspection program was inadequate.

The company did not adequately validate the analytical test procedures used in the stability program.

The quality control department was not involved in all decisions for the quality of the product.