1Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
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
2Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
3Other quality system
The assessment to release finished products was inadequate.
4Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
6Aseptic processing and sterility assurance
The process was inadequate for the environmental classification of aseptic or clean areas. The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Other quality system
The suitability of the culture media was not verified.
9Laboratory and QC controls
The quality control department's selection of a laboratory for testing and/or examination was inadequate.
10Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
11Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
12Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
13Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
14Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
15Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-11-06. 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.
