1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Covar Pharmaceuticals 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 handling of standard operating procedures for good manufacturing practices was inadequate.
3Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
6Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
7Laboratory and QC controls
The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-10-17. 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.
