1Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
Inspection Record
OmniaBio Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Deviation, CAPA, and investigation
When the particulate and microbiological limits were exceeded, the company's operating procedures did not prescribe an investigation and implementation of corrective actions.
4Aseptic processing and sterility assurance
Evaluation of production processes, equipment, and/or materials was inadequate. The operators'aseptic practices were inadequate to maintain sterility.
5Aseptic processing and sterility assurance
The samples taken for sterility testing were not representative of the whole batch.
6Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-09-21. 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.
