Juno OTC Inc. — Health Canada Inspection Findings

The company did not adequately validate the analytical test procedures used in the stability program. The company did not determine the stability of the drug before it was marketed or before significant changes were made to the drug formulations, fabrication procedures, or packaging materials.

Validation studies were not conducted in keeping with the predefined protocols.

The implementation of a self-inspection program was inadequate.

The quality control department did not ensure a thorough investigation and/or evaluation of complaints concerning potentially defective products.

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

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 change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.

The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.

The validation and/or the documentation of test methods was inadequate. The written protocol and/or the assessment of the test method transfer was inadequate.