1Other quality system
The assessment to release finished products was inadequate.
Inspection Record
Eurofins CDMO Alphora Incorporated — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The monitoring procedures for microbial and/or environmental conditions were inadequate.
3Stability and storage
Reworked or reprocessed drug lots were not included in the ongoing stability program.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-03. 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.
