1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
NUCM Radiopharma Inc. — 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.
3Laboratory and QC controls
The validation of test methods was inadequate. The evidence required to demonstrate compliance with finished product specifications was inadequate.
4Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Other quality system
The suitability of the culture media was not verified.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The temperature and/or humidity control was inadequate.
7Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
8Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
9Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
10Other quality system
The assessment to release finished products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-08-23. 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.
