1Equipment 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.
Inspection Record
Canadian Custom Packaging Company — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The maintenance of records was inadequate.
3Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
8Stability and storage
The temperature and/or humidity control was inadequate.
9Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
10Validation and qualification
Qualified personnel did not adequately supervise the fabrication, packaging, labelling, testing, and/or storage of drugs. The number of personnel with the necessary qualifications and/or on-site experience was inadequate.
11Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
12Other quality system
The assessment to release finished products was inadequate.
13Equipment and facility
The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The maintenance of the premises was inadequate.
14Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The availability, implementation, and/or quality of the written sanitation program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-03-05. 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.
