A.9 Section C.02.012(1)(a) of the Food and Drug Regulations requires that every fabricator,
packager/labeller, distributor, importer, and wholesaler of a drug maintains a system of control that permits
complete and rapid recall of any lot of batch of the drug that is on the market. Such a system must be tailored
to an individual organization and operation.
A written recall system should be in place to ensure compliance with Section C.01.051 of the Food and Drug
Regulations and should include the requirements outlined in Interpretations 1.1 to 1.11 under Section
C.02.012 Manufacturing Control of the “Good Manufacturing Practices Guidelines, 2009 Edition (GUI0001)”.
