1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Prometic Bioproduction Inc. dba Kedrion Biopharma Canada — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
4Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
5Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
6Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
7Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-09-01. 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.
