Inspection Record

Duchesnay Inc. — Health Canada Inspection Findings

Health CanadaInspected 2021-03-29 5 findingsCleaning validationMaterial and supplier controlOther quality systemEquipment and facilityStability and storage

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

Findings

1Cleaning validation

The availability, implementation, and/or quality of the written sanitation program was inadequate. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

2Material and supplier control

Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.

3Other quality system

The recorded information or details were inadequate.

4Equipment and facility

Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.

5Stability and storage

The stability program did not include batches of drugs that had been stored for extended periods of time before they were packaged.

About this record

Extracted automatically from the document of the Health Canada inspection on 2021-03-29. 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

Duchesnay Inc. findings history — including this company's other documentsAll Health Canada findings Health Canada documents, 2021 Go to Findings search
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