1Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
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
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Other quality system
The assessment to release finished products was inadequate.
7Training and personnel
The ongoing training of personnel was inadequate.
8Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
9Stability 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 2021-02-08. 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.
