1Computer system validation
The computerized system used to manage product inventory and distribution records to support recalls was not validated.
Inspection Record
Quantus Products & Services 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.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-24. 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.
