1Other quality system
The assessment to release finished products was inadequate.
Inspection Record
Laboratoire Lalco 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.
3Laboratory and QC controls
The establishment of specifications was inadequate for packaging materials approved by the quality control department.
4Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
5Quality unit oversight
The annual product quality review procedure was inadequate.
6Equipment 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-11-15. 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.
