Confab Laboratories, Inc. — Health Canada Inspection Findings

The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.

The written specifications were inadequate.

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

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

The verification and dispensing of raw materials by qualified staff was inadequate. As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.

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 creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The preventative maintenance and repair of the equipment was inadequate.

The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.

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).