1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
Inspection Record
BWXT Medical Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
3Other quality system
The "Water for Injection" was not produced, stored or distributed to prevent microbial growth.
4Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
5Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization.
6Training and personnel
The written hygiene program was not being followed by plant personnel and/or visitors.
7Aseptic processing and sterility assurance
The number of samples taken for environmental monitoring was insufficient. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
8Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
9Computer 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 2026-05-11. 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.
