1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
9510-3099 Québec Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
3Equipment 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.
4Complaint and recall handling
The written procedures for recalls were inadequate.
5Other quality system
The written self-inspection procedure was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
8Other quality system
The recorded information or details were inadequate.
9Other quality system
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.
10Laboratory and QC controls
The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
11Stability and storage
The temperature and/or humidity control was 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.
12Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
13Laboratory and QC controls
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.
14Contamination control
The control of quarantine areas was inadequate. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
15Equipment and facility
The maintenance of records was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
16Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-10-09. 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.
