1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
A&L Canada Laboratories Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The company's monitoring of water testing was inadequate.
3Laboratory and QC controls
The validation of test methods was inadequate.
4Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Computer system validation
The establishment and/or the maintenance of a data governance plan was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. 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 2024-09-04. 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.
