1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
HYTN Cannabis Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Material and supplier control
Lots and/or batches of packaging materials were not examined and/or tested against the written specifications before they were used.
4Laboratory and QC controls
The quality control department did not undertake all of the required activities.
5Training and personnel
The written hygiene program was not being followed by plant personnel and/or visitors.
6Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
7Computer system validation
The preventative maintenance and repair of the equipment was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
9Other quality system
The assessment to release finished products was inadequate.
10Other quality system
The company's oversight of the contracted party was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-08. 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.
