1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
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
2Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
3Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
4Stability 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.
5Material and supplier control
Lots and/or batches of packaging materials were not examined and/or tested against the written specifications before they were used.
6Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Equipment and facility
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose
9Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
10Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
11Computer system validation
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The electronic system was not validated for its intended use.
12Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-22. 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.
