1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Columbia Laboratories Canada 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 controls put in place for electronic signatures were inadequate.
3Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
4Other quality system
The availability or the content of the authentic certificate of analysis was inadequate. The content of the batch certificate was inadequate. The assessment to release finished products was inadequate.
5Deviation, 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 2023-05-30. 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.
