1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were 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
2Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
3Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
4Other quality system
The company's visual inspection of filled containers was inadequate.
5Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
6Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
7Deviation, CAPA, and investigation
The airborne particle monitoring system was inadequate. The company's investigations of microbial contamination in critical areas were inadequate.
8Equipment and facility
The maintenance of records was inadequate.
9Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-21. 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.
