1Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
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
2Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
3Material and supplier control
The sampling plan for raw materials was inadequate. The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate. Complete confirmatory testing was not conducted on raw materials from each vendor.
4Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
5Other quality system
The company's monitoring of water testing was inadequate.
6Stability 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.
7Stability and storage
The ongoing stability program for a drug was inadequate.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
10Material and supplier control
The drug fabricator's specifications for raw materials were inadequate. The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards.
11Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
12Equipment and facility
The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate. 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 before new or revised standard operating procedures were implemented was inadequate. The maintenance of personnel records was inadequate.
13Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
14Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
15Laboratory and QC controls
The validation of test methods was inadequate.
16Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
17Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-08. 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.
