1Material and supplier control
The sampling plan for raw materials was inadequate. Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
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
2Other quality system
The written procedures and records for retaining samples were inadequate.
3Material and supplier control
A reduced retesting program for raw materials was in place without the raw material vendor certification. The standard operating procedures or records for shipping and receiving raw materials were inadequate.
4Stability 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.
5Other quality system
The assessment to release finished products was inadequate.
6Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
7Laboratory 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.
8Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The ongoing training of personnel was inadequate.
9Equipment 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.
10Quality unit oversight
The annual product quality review procedure was inadequate.
11Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate. The temperature and/or humidity control was inadequate.
12Other quality system
The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.
13Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
14Stability and storage
The ongoing stability program for a drug was inadequate.
15Labeling and packaging
The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate. The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
16Computer system validation
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
17Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
18Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
19Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-04-11. 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.
