1Other quality system
The implementation of a self-inspection program was inadequate. The written self-inspection procedure was inadequate.
Inspection Record
Ontario Medical Supply Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The system for reviewing, revising, and approving standard operating procedures was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
3Laboratory and QC controls
The quality control department did not release the materials that were used.
4Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
5Equipment and facility
The training of personnel before new or revised standard operating procedures were implemented was inadequate. The ongoing training of personnel was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
6Stability and storage
The temperature and/or humidity control was inadequate. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
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.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
10Stability and storage
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The identification and storage of recalled products was inadequate.
11Other quality system
The assessment of the contractor's competencies by the fabricator, packager/labeller, distributor, or importer was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-29. 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.
