1Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
Inspection Record
Biologics Manufacturing Centre (BMC) 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 design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
5Material and supplier control
The specifications for any packaging materials were incomplete or inadequate.
6Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Stability and storage
The temperature and/or humidity control was inadequate.
9Other quality system
The recorded information or details were inadequate.
10Aseptic processing and sterility assurance
Evaluation of production processes, equipment, and/or materials was inadequate. Sterile disinfectants were not used in Grade A and B areas. The company did not monitor the aseptic filling area frequently enough to avoid possible contamination or system deterioration. The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
11Material and supplier control
The protection of products and/or materials from contamination was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-05-13. 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.
