1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Diagnostic Imaging, Nova Scotia Health Authority — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Material and supplier control
The company did not retain a sample of each lot or batch of a drug, raw material, and/or an active ingredient for the required amount of time.
4Other quality system
The master formulas to control the manufacturing process were inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Aseptic processing and sterility assurance
The samples taken for sterility testing were not representative of the whole batch.
7Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
8Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
9Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
10Other quality system
The written specifications were inadequate.
11Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
12Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-07-24. 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.
