1Labeling and packaging
The name and batch number of the product being handled was not displayed at each packaging station or line.
Inspection Record
Jamieson Laboratories 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 assessment to release finished products was inadequate.
3Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Other quality system
The master production documents were inadequate. The recorded information or details were inadequate.
9Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
10Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
11Stability and storage
The temperature and/or humidity control was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-17. 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.
