HK Kolmar Canada, Inc. — Health Canada Inspection Findings

The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.

The ongoing training of personnel was inadequate.

The receipt, preparation, and/or handling of reagents and culture media was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The design, equipment, and/or maintenance of the testing laboratory was inadequate.

Evaluation of production processes, equipment, and/or materials was inadequate.

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was 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 calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. Measuring devices were not regularly checked for accuracy and precision. 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 investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The implementation of a self-inspection program was inadequate.

The master production documents were inadequate. The recorded information or details were inadequate.

The quality control department's approval was inadequate for raw materials, packaging materials, labelling, finished products, and/or products being reprocessed.

The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate. The quality control department was not involved in all decisions for the quality of the product.

Investigations into deviations, reports, and/or follow-up actions were inadequate. The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.