HYTN Cannabis Inc. — Health Canada Inspection Findings

The company did not retain a sample of each lot or batch of a drug, raw material, and/or an active ingredient for the required amount of time. The written procedures and records for retaining samples were inadequate.

The quality control department's documentation, labelling, and/or quarantining of raw materials, packaging materials, in-process drugs, and/or bulk drugs was inadequate. Line clearance was not performed before starting new processing operations. The protection of products and/or materials from contamination was inadequate. As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record. Printed packaging materials were not stored in an area with restricted access.

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 evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.

The written self-inspection procedure 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 control of quarantine areas was inadequate.

The specifications for any packaging materials were incomplete or inadequate. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.

Measuring devices were not regularly checked for accuracy and precision. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

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

The assessment to release finished products was inadequate. The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch. The quality control department's approval was inadequate for raw materials, packaging materials, labelling, finished products, and/or products being reprocessed.

The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions. The labelling of outlets for liquids and/or gases was inadequate.

The maintenance of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

A sample from each lot of raw materials was not fully tested against the specifications. The sampling plan for raw materials was inadequate. The specifications approved by the quality control department were not available for all raw materials used to produce drugs.

A reduced retesting program for raw materials was in place without the raw material vendor certification.

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 implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.