1Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Transpharm Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The master formulas to control the manufacturing process were inadequate.
3Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
6Equipment and facility
The control of quarantine areas was inadequate. Separate rooms were not provided and/or maintained to adequately protect equipment and control systems.
7Stability 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-12-08. 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.
