Inspection Record

uniPHARM Wholesale Drugs Ltd. — Health Canada Inspection Findings

Health CanadaInspected 2023-02-08 5 findingsRegulatory reporting and change controlDeviation, CAPA, and investigationEquipment and facilityLaboratory and QC controlsStability and storage

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

Findings

1Regulatory reporting and change control

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

2Deviation, CAPA, and investigation

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

3Equipment and facility

The establishment and/or the maintenance of a data governance plan was inadequate.

4Laboratory and QC controls

The system for reviewing, revising, and approving standard operating procedures was inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

5Stability and storage

The temperature and/or humidity control was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2023-02-08. 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.

uniPHARM Wholesale Drugs Ltd. company profile — full history Health Canada documents, 2023 Go to Findings search