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
West Penetone Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Critical production processes were not validated.
3Complaint and recall handling
The written procedures for recalls were inadequate.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Equipment and facility
The maintenance of records was inadequate.
6Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
9Material and supplier control
The sampling plan for raw materials was inadequate.
10Other quality system
The electronic system was not validated for its intended use.
11Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
12Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-02-21. 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.
