1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Carbon Extracts Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The temperature and/or humidity control was inadequate.
3Material and supplier control
The master production documents were inadequate. The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate.
4Equipment and facility
The ongoing training of personnel was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Material and supplier control
The sampling plan for raw materials was inadequate.
6Laboratory and QC controls
The quality control department's release of packaging materials for use in packaging or labelling was inadequate.
7Complaint and recall handling
The handling of standard operating procedures for good manufacturing practices was inadequate. The written procedures for recalls were inadequate.
8Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.
9Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The retention time for records was inadequate.
10Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
11Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
12Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-07-14. 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.
