1Training and personnel
The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.
Inspection Record
ILS Pharma Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The preventative maintenance and repair of the equipment was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
4Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The expiry date of the prepared culture media was not supported by the growth-promotion testing. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-11-14. 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.
