1Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
Inspection Record
Groupe Dissan Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The quality control department's approval was inadequate for raw materials, packaging materials, labelling, finished products, and/or products being reprocessed.
3Other quality system
Documents were not available on the premises. The recorded information or details were inadequate.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Computer system validation
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Other quality system
The company used sample retention sites outside of Canada without sending a request to Health Canada.
7Laboratory and QC controls
The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Other quality system
The electronic system was not validated for its intended use.
10Laboratory and QC controls
The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
11Stability and storage
The temperature and/or humidity control was inadequate.
12Laboratory and QC controls
The duties of the individual in charge of the quality control department were delegated to an unqualified individual.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-10-19. 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.
