Inspection Record

Shinpharma Inc — Health Canada Inspection Findings

Health CanadaInspected 2022-12-01 4 findingsStability and storageRegulatory reporting and change controlOther quality system

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

Findings

1Stability and storage

The temperature and/or humidity control was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.

2Regulatory reporting and change control

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

3Other quality system

The responsibilities for annual product quality reviews were not adequately addressed in the agreement between each party involved.

4Other quality system

Documents were not available on the premises.

About this record

Extracted automatically from the document of the Health Canada inspection on 2022-12-01. 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.

Shinpharma Inc company profile — full history Health Canada documents, 2022 Go to Findings search