1Stability and storage
The temperature and/or humidity control was inadequate.
Inspection Record
Gurvey & Berry Co. Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Material and supplier control
The standard operating procedures or records for shipping and receiving raw materials were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-08-20. 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.
