Inspection Record

Voyant Beauty, Inc. — Health Canada Inspection Findings

Health CanadaInspected 2021-06-14 9 findingsOther quality systemEquipment and facilityDeviation, CAPA, and investigationRegulatory reporting and change controlStability and storageMaterial and supplier controlLaboratory 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 master production documents were inadequate. Evaluation of production processes, equipment, and/or materials was inadequate.

3Deviation, CAPA, and investigation

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

4Regulatory reporting and change control

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

5Stability and storage

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.

6Material and supplier control

The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.

7Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

8Other quality system

The evidence required to demonstrate compliance with finished product specifications was inadequate.

9Deviation, 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

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