1Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
Inspection Record
Pillar5 Pharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
3Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Laboratory and QC controls
The validation of test methods was inadequate.
6Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
7Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
8Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
9Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
10Aseptic processing and sterility assurance
The testing of the isolator and the glove or sleeve system for leaks was inadequate. The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
11Stability and storage
The temperature and/or humidity control was inadequate.
12Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-21. 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.
