1Other quality system
The content of the batch certificate was inadequate.
Inspection Record
Pancap Pharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Other quality system
The implementation of a self-inspection program was inadequate.
6Equipment and facility
The maintenance of the premises was inadequate.
7Equipment and facility
The maintenance of personnel records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
10Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
11Computer 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 2023-01-10. 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.
