The maintenance of records was inadequate.
Inspection Record
Cipher Pharmaceuticals Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
There was a lack of or inadequate evidence to demonstrate that all buildings involved in the production, distribution and/or importation of APIs met good manufacturing practices requirements.
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-02-07. 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.
