1Equipment and facility
The maintenance of records 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
2Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The master production documents were inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Stability and storage
The ongoing stability program for a drug was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
8Other quality system
The assessment to release finished products was inadequate.
9Other quality system
The implementation of a self-inspection program was inadequate.
10Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
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.
12Labeling 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).
13Laboratory and QC controls
The validation of test methods was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-08. 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.
