1Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
Inspection Record
Pharmaris Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Computer system validation
The computerized system used to manage product inventory and distribution records to support recalls was not validated.
4Other quality system
The company did not retain large enough samples to allow duplicate testing by the company and Health Canada. The written procedures and records for retaining samples were inadequate.
5Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
6Validation and qualification
The temperature and/or humidity control was inadequate. The control of quarantine areas was inadequate. The qualification and/or verification of utilities and/or support systems was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-01-19. 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.
