SV Labs Toronto Corporation — Health Canada Inspection Findings

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The ongoing training of personnel was inadequate.

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

The preventative maintenance and repair of the equipment was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.

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

Validation studies were not conducted in keeping with the predefined protocols. The in-process control activities in the production areas risked the quality of the product.

The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The master production documents were inadequate.

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

The electronic system was not validated for its intended use.

The standard operating procedures or records for shipping and receiving raw materials were inadequate. 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 written specifications were inadequate.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.

The maintenance of the premises 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 qualification and/or verification of utilities and/or support systems was inadequate. The labelling of outlets for liquids and/or gases was inadequate.

The assessment to release finished products was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The sampling plan for raw materials was inadequate. The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.

The availability, implementation, and/or quality of the written sanitation program was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.