1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The system for reviewing, revising, and approving standard operating procedures was inadequate.
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
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
4Equipment and facility
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
5Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The training of personnel before new or revised standard operating procedures were implemented was inadequate.
6Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
7Laboratory and QC controls
The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
8Other quality system
The written specifications were inadequate.
9Regulatory 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 2021-01-13. 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.
