Inspection Record

Thea Pharma, Inc — Health Canada Inspection Findings

Health CanadaInspected 2023-11-15 6 findingsStability and storageDeviation, CAPA, and investigationEquipment and facilityRegulatory reporting and change controlOther quality systemComplaint and recall handling

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

Findings

1Stability and storage

The ongoing stability program for a drug was inadequate.

2Deviation, CAPA, and investigation

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

3Equipment and facility

The maintenance of records was inadequate.

4Regulatory reporting and change control

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

5Other quality system

The assessment to release finished products was inadequate.

6Complaint and recall handling

The quality control department's handling of complaints and/or information received about drug quality was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2023-11-15. 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.

Thea Pharma, Inc company profile — full history Health Canada documents, 2023 Go to Findings search