Germiphene Corporation — 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 availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The maintenance of records was inadequate.

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

The design, equipment, and/or maintenance of the testing laboratory was inadequate.

The identity testing of primary packaging materials once they were received on the premises by a person that packages the drugs was inadequate.

The ongoing stability program for a drug was inadequate.

The availability, implementation, and/or quality of the written sanitation program was inadequate.

The receipt, preparation, and/or handling of reagents and culture media was inadequate.

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