1Other quality system
The written specifications were inadequate.
Inspection Record
All Clean Natural Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.
3Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
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.
5Other quality system
The company's oversight of the contracted party was inadequate.
6Training and personnel
The ongoing training of personnel was inadequate.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
8Material and supplier control
The company did not determine the stability of the drug before it was marketed or before significant changes were made to the drug formulations, fabrication procedures, or packaging materials.
9Material and supplier control
The control of quarantine areas was inadequate. The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.
10Stability and storage
The temperature and/or humidity control was inadequate.
11Other quality system
The master production documents were inadequate.
12Other quality system
Complete testing was not performed according to the requirements.
13Computer system validation
The computerized system used to manage product inventory and distribution records to support recalls was not validated. The distribution records did not allow each drug to be traced individually.
14Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-01. 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.
