1Equipment and facility
The maintenance and/or monitoring of the ventilation system's air quality was inadequate. The maintenance of the premises was inadequate.
Inspection Record
Eurofins CDMO Alphora Incorporated — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Other quality system
Measures to ensure the compliance of the contracted test laboratories were inadequate.
4Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
5Stability and storage
The temperature and/or humidity control was inadequate.
6Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
8Other quality system
The implementation of a self-inspection program was inadequate.
9Complaint and recall handling
The written procedures for recalls were inadequate.
10Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
11Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
12Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The recorded information or details were inadequate.
13Computer 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 2022-05-05. 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.
