1Stability and storage
The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.
Inspection Record
Chief Medical Supplies Ltd — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment 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.
3Laboratory and QC controls
The quality control department's documentation, labelling, and/or quarantining of raw materials, packaging materials, in-process drugs, and/or bulk drugs was inadequate.
4Equipment and facility
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Other quality system
The recorded information or details were inadequate.
6Laboratory and QC controls
The validation of test methods was inadequate.
7Other quality system
The master production documents were inadequate. Documents were not available in one of the official languages.
8Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
9Laboratory and QC controls
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate. The quality control department did not undertake all of the required activities.
10Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
11Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
12Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The electronic system was not validated for its intended use.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-20. 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.
