1Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The maintenance of records 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
2Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Equipment and facility
The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The maintenance of the premises was inadequate.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Other quality system
The recorded information or details were inadequate. The assessment to release finished products was inadequate.
7Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Stability and storage
The ongoing stability program for a drug was inadequate.
10Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
11Laboratory and QC controls
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. The duties of the individual in charge of the quality control department were delegated to an unqualified individual. The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
12Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-04-08. 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.
