1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Neilmed Pharmaceuticals Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The temperature and/or humidity control was inadequate.
3Material and supplier control
The written procedures and records for retaining samples were inadequate. The company did not retain a sample of each lot or batch of a drug, raw material, and/or an active ingredient for the required amount of time.
4Equipment and facility
The handling of standard operating procedures for good manufacturing practices was inadequate. The maintenance of records was inadequate.
5Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The controls put in place for electronic signatures were inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-03-25. 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.
