1Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
Inspection Record
Curia New Mexico, LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
3Aseptic processing and sterility assurance
The documentation for the integrity testing of sterilizing filters was inadequate.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Aseptic processing and sterility assurance
The sterilization process did not align with the marketing and manufacturing authorization.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-23. 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.
