Inspection Record

CellBioasis Inc — Health Canada Inspection Findings

Health CanadaInspected 2025-04-16 5 findingsComplaint and recall handlingDeviation, CAPA, and investigationOther quality systemStability and storage

View the regulator's official source The source document is always the basis for judgement.

Findings

1Complaint and recall handling

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

2Deviation, CAPA, and investigation

Investigations into deviations, reports, and/or follow-up actions were inadequate.

3Other quality system

Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale.

4Stability 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. The handling of standard operating procedures for good manufacturing practices was inadequate.

5Stability 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.

About this record

Extracted automatically from the document of the Health Canada inspection on 2025-04-16. 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.

CellBioasis Inc company profile — full history Health Canada documents, 2025 Go to Findings search