Xenex Laboratories 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 availability, implementation, and/or quality of the written sanitation program was inadequate. The monitoring procedures for microbial and/or environmental conditions were inadequate.

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

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative. The written specifications were inadequate.

The written self-inspection procedure was inadequate.

The written hygiene program was not being followed by plant personnel and/or visitors.

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

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.