1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Patris Holdings 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
The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.
3Stability and storage
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
4Equipment and facility
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.
5Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.
6Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
9Other quality system
The implementation of a self-inspection program was inadequate.
10Equipment 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.
11Other 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.
12Deviation, CAPA, and investigation
The assessment to release finished products was inadequate. The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
13Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
14Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
15Quality unit oversight
The annual product quality review procedure was inadequate.
16Other quality system
The master formula for packaged products did not include the required information.
17Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
18Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
19Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-19. 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.
