1Deviation, CAPA, and investigation
The deviation investigations to reconcile bulk product or printed packaging materials were inadequate.
Inspection Record
Capcium Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability 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.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Laboratory and QC controls
The receipt, preparation, and/or handling of reagents and culture media was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
5Laboratory and QC controls
The quality control department did not undertake all of the required activities.
6Other quality system
The master formulas to control the manufacturing process were inadequate.
7Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Equipment and facility
The maintenance of the premises was inadequate.
10Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-05-01. 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.
