1Equipment and facility
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.
Inspection Record
Novocol Pharmaceutical of Canada Inc. — 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 documentation for the integrity testing of sterilizing filters was inadequate.
3Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
4Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
5Aseptic processing and sterility assurance
The process was inadequate for the environmental classification of aseptic or clean areas.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug.
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.
