1Equipment and facility
The maintenance and/or monitoring of the ventilation system's air quality was inadequate. The qualification and/or verification of utilities and/or support systems was inadequate.
Inspection Record
Sciences de la Peau Crescita Inc. / Crescita Skin Sciences Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The implementation of a self-inspection program was inadequate.
3Equipment and facility
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.
5Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The availability, implementation, and/or quality of the written sanitation program was inadequate.
6Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Laboratory and QC controls
The quality control department was not involved in all decisions for the quality of the product. The assessment to release finished products was inadequate.
8Other quality system
The written procedures and records for retaining samples were inadequate.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The quality control department did not undertake all of the required activities.
10Stability and storage
The temperature and/or humidity control was inadequate.
11Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
12Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-02-10. 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.
