1Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
Inspection Record
Odan Laboratories Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
3Equipment and facility
The maintenance of the premises was inadequate.
4Equipment 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. The assessment of the contractor's competencies by the fabricator, packager/labeller, distributor, or importer was inadequate.
5Quality unit oversight
The annual product quality review procedure was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Stability 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.
8Laboratory and QC controls
The quality control department did not undertake all of the required activities.
9Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
10Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
11Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
12Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-03-12. 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.
