1Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The ongoing training of personnel was inadequate.
Inspection Record
University Health Network Radiotheranostics Core — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
The monitoring procedures for microbial and/or environmental conditions were inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate. Critical production processes were not validated.
7Material and supplier control
A reduced retesting program for raw materials was in place without the raw material vendor certification.
8Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
10Material and supplier control
The company did not store a sample from each lot or batch of a drug, raw material, and/or an active ingredient under the proper conditions.
11Other quality system
The master production documents were inadequate.
12Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-09-11. 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.
