Inspection Record

McGuff Medical Canada Inc. — Health Canada Inspection Findings

Health CanadaInspected 2023-01-12 4 findingsStability and storageRegulatory reporting and change controlLaboratory and QC controlsDeviation, CAPA, and investigation

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. The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .

2Regulatory reporting and change control

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

3Laboratory and QC controls

The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

4Deviation, CAPA, and investigation

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

About this record

Extracted automatically from the document of the Health Canada inspection on 2023-01-12. 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.

McGuff Medical Canada Inc. company profile — full history Health Canada documents, 2023 Go to Findings search