1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Winnipeg Regional Health Authority — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
3Equipment and facility
The maintenance of records was inadequate. The electronic system was not validated for its intended use.
4Laboratory and QC controls
The quality control department's approval was inadequate for raw materials, packaging materials, labelling, finished products, and/or products being reprocessed.
5Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
6Laboratory and QC controls
The quality control department was not involved in all decisions for the quality of the product.
7Laboratory and QC controls
The quality control department's access to adequate facilities, trained personnel, materials, and/or equipment was inadequate to fulfill its duties and responsibilities.
8Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The ongoing training of personnel was inadequate.
9Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-30. 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.
