1Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
Applied Chemistry Labs 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 recorded information or details were inadequate.
3Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The ongoing training of personnel was inadequate.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Equipment and facility
The maintenance of records was inadequate.
6Equipment and facility
The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
7Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-11-07. 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.
