1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
BLES Biochemicals Inc — 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 traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate.
3Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Contamination control
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Equipment and facility
The maintenance of records was inadequate.
9Material and supplier control
The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.
10Contamination control
The qualification and/or verification of utilities and/or support systems was inadequate. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
11Aseptic processing and sterility assurance
The environmental sampling methods were inadequate. The operators'aseptic practices were inadequate to maintain sterility.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-24. 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.
