1Material and supplier control
Each lot or batch of raw materials was not tested against the raw material specifications before it was used to fabricate a drug.
Inspection Record
Lawson Health Research Institute — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The validation of test methods was inadequate.
3Quality unit oversight
The annual product quality review procedure was inadequate.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Other quality system
The airborne particle monitoring system was inadequate. The company did not set appropriate alert and action limits for the results of particulate and microbiological monitoring.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-28. 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.
