1Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
Inspection Record
Groupe Marcelle Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The maintenance of records was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
4Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
5Computer system validation
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Other quality system
The master production documents were inadequate.
9Computer system validation
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
10Stability and storage
The ongoing stability program for a drug was inadequate.
11Stability 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 2021-05-17. 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.
