1Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The monitoring procedures for microbial and/or environmental conditions were 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
2Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
3Other quality system
The recorded information or details were inadequate.
4Other quality system
The company's visual inspection of filled containers was inadequate.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
8Laboratory and QC controls
The quality control department did not undertake all of the required activities.
9Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
10Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The maintenance of records was inadequate.
11Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
12Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
13Computer system validation
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 2024-11-12. 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.
