1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
Dermolab Pharma Ltée — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
The training for the individual responsible for the manufacturing operations was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
5Other quality system
The implementation of a self-inspection program was inadequate.
6Equipment and facility
The maintenance of records was inadequate.
7Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
8Material and supplier control
The handling of rejected materials and products was inadequate.
9Stability and storage
The temperature and/or humidity control was inadequate.
10Other quality system
Measuring devices were not regularly checked for accuracy and precision.
11Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
12Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
13Deviation, 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 2024-05-21. 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.
