1Equipment 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.
Inspection Record
Oral Science Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
3Other quality system
The electronic system was not validated for its intended use.
4Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Complaint and recall handling
The written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Equipment and facility
The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
8Laboratory 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.
9Quality unit oversight
The annual product quality review procedure was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-31. 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.
