1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
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
2Other quality system
The company's monitoring of water testing was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Other quality system
The assessment to release finished products was inadequate.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
6Other quality system
The written clothing standards for each environmental grade were inadequate.
7Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Quality unit oversight
Critical processes and procedures were not evaluated on a regular basis. The annual product quality review procedure was inadequate.
10Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
11Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
12Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
13Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. The company did not adequately protect sterilized material to prevent re-contamination after sterilization.
14Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
15Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The company did not set appropriate alert and action limits for the results of particulate and microbiological monitoring.
16Other quality system
The recorded information or details were inadequate.
17Aseptic processing and sterility assurance
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination. The process was inadequate for the environmental classification of aseptic or clean areas.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-12-02. 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.
