1Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
Inspection Record
Chief Medical Supplies Ltd — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Lots or batches of finished product were not examined or tested against the specifications before they were fabricated or sold. The written specifications were inadequate.
3Other quality system
The contracted testing site did not have a valid establishment license.
4Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Other quality system
Operations on different products were carried out simultaneously or consecutively in the same room. Line clearance was not performed before starting new processing operations.
7Other quality system
The control of quarantine areas was inadequate.
8Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-09-23. 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.
