1Other quality system
The company's oversight of the contracted party was inadequate.
Inspection Record
Protonify Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Validation and qualification
Validation studies were not conducted in keeping with the predefined protocols.
3Equipment and facility
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Other quality system
The master production documents were inadequate.
6Material and supplier control
The sampling plan for raw materials was inadequate. Each lot or batch of raw materials was not tested against the raw material specifications before it was used to fabricate a drug.
7Quality unit oversight
The annual product quality review procedure was inadequate.
8Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The system for reviewing, revising, and approving standard operating procedures was inadequate.
9Other quality system
The implementation of a self-inspection program was inadequate.
10Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
11Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
12Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
13Other quality system
The electronic system was not validated for its intended use.
14Computer system validation
The usage logs for the equipment used for significant processing and/or testing operations were inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
15Equipment 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.
16Other quality system
The written procedures and records for retaining samples were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-09-19. 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.
