Halo Pharmaceutical Canada Inc. — Health Canada Inspection Findings

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate. The recorded information or details were inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The assessment to release finished products was inadequate. The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The procedures to identify the contents of each container were inadequate.

The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose

"The maintenance of records was inadequate.

The drug fabricator's specifications for raw materials were inadequate.

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

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

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