1Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
Inspection Record
Isologic Innovative Radiopharmaceuticals Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
A reduced retesting program for raw materials was in place without the raw material vendor certification.
3Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
4Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
5Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Aseptic processing and sterility assurance
The portable particle counters were inadequate to classify the airborne particulates in aseptic or clean areas.
7Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
8Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
9Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
10Complaint and recall handling
The written self-inspection procedure was inadequate. The written procedures for recalls were 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.
12Laboratory and QC controls
The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-03-01. 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.
