1Other quality system
Complete testing was not performed according to the requirements.
Inspection Record
Athena Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The written procedures for recalls were inadequate.
3Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080). The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate. The company's oversight of the contracted party was inadequate.
4Other quality system
The written self-inspection procedure was inadequate.
5Stability and storage
The ongoing stability program for a drug was inadequate.
6Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-03-29. 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.
