Guidance on classification of observations for inspecting cells, tissues and organs establishments (GUI-0101): Glossary

These definitions explain how terms are used in this document. If there is a conflict with a definition in the Food and Drugs Act (act) or the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO regulations), the definition in the act or regulations prevails.

Exit notice

A report listing the observations and/or violations of the Food and Drugs Act and regulations found during an inspection.

Inspections

Monitoring and assessment against the applicable requirements of the act and its associated regulations. Inspections are routinely conducted based on risk to assess compliance.

Observation

A deficiency in compliance with the act or the regulations noted during the inspection of an establishment and that is documented in the inspection report (exit notice). An observation is classified according to the level of risk associated with the deficiency.