1Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
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
2Cleaning validation
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
3Other quality system
The assessment to release finished products was inadequate.
4Equipment and facility
The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging. The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building. The premises were not laid out and/or designed for an optimal flow of personnel and/or materials to prevent cross-contamination and/or mix-ups between products.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
7Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Other quality system
The recorded information or details were inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.
9Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
10Stability 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.
11Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-24. 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.
