1Laboratory and QC controls
The quality control department did not undertake all of the required activities.
Inspection Record
Air Liquide 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
Evaluation of production processes, equipment, and/or materials was inadequate.
3Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Other quality system
The implementation of a self-inspection program was inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.
8Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
9Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
10Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
11Other quality system
The master formulas to control the manufacturing process were inadequate.
12Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-13. 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.
