1Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug 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
2Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
3Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
4Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
5Deviation, CAPA, and investigation
The company's investigations of microbial contamination in critical areas were inadequate.
6Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
7Aseptic processing and sterility assurance
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The operators'aseptic practices were inadequate to maintain sterility.
8Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
9Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-12-09. 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.
