Inspection Record

GlaxoSmithKline Inc. — Health Canada Inspection Findings

Health CanadaInspected 2021-06-14 4 findingsStability and storageOther quality systemLabeling and packagingDeviation, 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.

2Other quality system

The handling of standard operating procedures for good manufacturing practices was inadequate. The master production documents were inadequate.

3Labeling and packaging

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

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 2021-06-14. 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.

Other records for this company

2025-09-15 · Health Canada · 3 findings2021-06-14 · Health Canada · 4 findings
GlaxoSmithKline Inc. findings history — including this company's other documents Health Canada documents, 2021 Go to Findings search