1Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
Inspection Record
Beauty Mark Solutions Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Laboratory and QC controls
The validation of test methods was inadequate.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The master production documents were inadequate.
5Other quality system
The implementation of a self-inspection program was inadequate.
6Labeling 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).
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Stability and storage
The ongoing stability program for a drug was inadequate.
9Other quality system
The assessment to release finished products was inadequate.
10Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
11Quality unit oversight
The annual product quality review procedure was inadequate. The quality control department did not evaluate the results of the annual product quality review.
12Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
13Material and supplier control
The company did not determine the stability of the drug before it was marketed or before significant changes were made to the drug formulations, fabrication procedures, or packaging materials.
14Equipment and facility
The maintenance of records was inadequate.
15Other quality system
The written specifications were inadequate.
16Laboratory and QC controls
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate. The quality control department did not undertake all of the required activities.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-07-25. 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.
