1Quality unit oversight
The annual product quality review procedure was inadequate.
Inspection Record
Messer Canada Inc. — 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 usage logs for the equipment used for significant processing and/or testing operations were inadequate. The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
4Material and supplier control
The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.
5Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
6Laboratory 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.
7Other quality system
The electronic system was not validated for its intended use.
8Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
9Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
10Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
11Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
12Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-04-26. 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.
