No. This Canadian site is a contract fabricator and not a distributor. Subsection C.02.025 (1) of the Food
and Drug Regulations (FDR) requires that a sample of each lot of the packaged/labelled drug be kept by the
distributor and the importer (not the fabricator). This is also applicable if the Canadian fabricator
manufactures a product for a Canadian distributor (Drug Identification Number (DIN) owner). While
subsection C.02.025(2) of the FDR for retained samples of raw materials, the requirement applies to the
fabricator (the person that transforms the raw material into a finished product), not the distributor.
Subsection C.02.025(2) of the FDR for retained samples of raw materials, applies to the fabricator (the
person that transforms the raw material into a finished product), not the distributor.
