1Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
Inspection Record
Trillium Health Care Products 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 implementation of a self-inspection program was inadequate.
3Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
4Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
5Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
6Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
9Documentation and records
As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-22. 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.
