1Other quality system
The suitability of the culture media was not verified. The expiry date of the prepared culture media was not supported by the growth-promotion testing.
Inspection Record
Sporometrics Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-03-03. 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.
