1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Innovarxi Ltd. — 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.
3Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
4Computer system validation
The computerized system used to manage product inventory and distribution records to support recalls was not validated.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-05-23. 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.
