1Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
Inspection Record
Voyant Beauty, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Equipment and facility
The master production documents were inadequate. Evaluation of production processes, equipment, and/or materials was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
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.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
8Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
9Other quality system
The records for rejecting or quarantining products were not maintained.
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.
