Findings
1Laboratory and QC controls
The implementation and/or maintenance of the quality management system was inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The handling of standard operating procedures for good manufacturing practices was inadequate. 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.
2Stability and storage
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 temperature and/or humidity control was inadequate.
3Equipment and facility
"The maintenance of records was inadequate.
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Other quality system
The premises were not laid out and/or designed to ensure that production areas were adequately isolated and segregated.
6Laboratory and QC controls
The number of personnel with the necessary qualifications and/or on-site experience was inadequate. The duties of the individual in charge of the quality control department were delegated to an unqualified individual. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The maintenance of personnel records was inadequate. The effectiveness of the training was not assessed by the firm.
7Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-04-03. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
