1Other quality system
The company's oversight of the contracted party was inadequate.
Inspection Record
Imperial Distributors Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
7Other quality system
The electronic system was not validated for its intended use.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-05-31. 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.
