1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
Resilience Biotechnologies Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The maintenance of the premises was inadequate.
3Material 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. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Aseptic processing and sterility assurance
The documentation for the integrity testing of sterilizing filters was inadequate.
9Contamination control
The availability, implementation, and/or quality of the written sanitation program was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
10Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
11Quality unit oversight
Critical processes and procedures were not evaluated on a regular basis. The annual product quality review procedure was inadequate.
12Equipment and facility
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination. The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
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.
