1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The labelling of outlets for liquids and/or gases was inadequate.
Inspection Record
N-Two Medical 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 job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Other quality system
The implementation of a self-inspection program was inadequate.
6Laboratory and QC controls
The quality control department's documentation, labelling, and/or quarantining of raw materials, packaging materials, in-process drugs, and/or bulk drugs was inadequate. Packaging operations were not performed in keeping with the written operating procedures or specifications.
7Complaint and recall handling
The written procedures for recalls were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-15. 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.
