Inspection Record

Alembic Pharmaceuticals Canada Ltd — Health Canada Inspection Findings

Health CanadaInspected 2021-05-28 3 findingsOther quality systemEquipment and facilityLaboratory and QC controls

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

Findings

1Other quality system

The handling of standard operating procedures for good manufacturing practices was inadequate.

2Equipment and facility

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

3Laboratory and QC controls

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2021-05-28. 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

2024-02-13 · Health Canada · 4 findings
Alembic Pharmaceuticals Canada Ltd findings history — including this company's other documents Health Canada documents, 2021 Go to Findings search