1Other quality system
Lots or batches of finished product did not comply with the specifications and were made available for further fabrication or sale.
Inspection Record
Nordic Pharma Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Other quality system
Documents were not available on the premises. The written specifications were inadequate.
5Stability and storage
The frequency of stability testing of a drug did not comply with the marketing authorization.
6Deviation, 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 2024-02-27. 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.
