Food and Drug Regulations

C.04.419 (1) A fabricator shall use and maintain a recordkeeping system according to which the fabricator shall

• (a) assign a personal identifier to each donor;

• (b) keep on the donor’s file a photograph of the donor or some other reliable means of identification; and

• (c) assign a unique identifier to the source plasma collected by the fabricator at each plasmapheresis session.

(2) The system shall be structured so that a fabricator may, based on a personal identifier or a unique identifier, identify the donor and retrieve sufficient records to permit the traceability and recall of source plasma.

(3) The fabricator shall keep the records referred to in subsection (2) indefinitely.