1Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
Inspection Record
Occy Laboratoire Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
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.
3Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
4Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. 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.
6Stability and storage
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
7Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
8Material and supplier control
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 drug fabricator's specifications for raw materials were inadequate.
9Equipment and facility
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 availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
10Equipment and facility
The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-27. 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.
