1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Biolyse Pharma Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Material and supplier control
Complete confirmatory testing was not conducted on raw materials from each vendor.
4Laboratory and QC controls
The quality control department did not undertake all of the required activities.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
6Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
7Laboratory and QC controls
The validation of test methods was inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
10Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-11-14. 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.
