1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification 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
2Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
5Other quality system
Critical production processes were not validated. Yields and/or the reconciled quantities were not checked at appropriate stages.
6Other quality system
Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water.
7Stability and storage
The temperature and/or humidity control was inadequate.
8Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-04-22. 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.
