1Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
Inspection Record
Jubilant Draximage Inc. dba Jubilant Radiopharma — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
3Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization.
4Other quality system
The recorded information or details were inadequate.
5Deviation, CAPA, and investigation
The company's investigations of microbial contamination in critical areas were inadequate.
6Complaint and recall handling
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The quality control department did not ensure a thorough investigation and/or evaluation of complaints concerning potentially defective products.
7Material and supplier control
The standard operating procedures or records for shipping and receiving raw materials were inadequate.
8Deviation, CAPA, and investigation
The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department. 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.
9Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-01-13. 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.
