Food and Drug Regulations

C.04.428 (1) In addition to the general record keeping requirements of this Division, every fabricator of human plasma shall keep for each donor

• (a) a record of the specific immunization program carried out for the purposes of plasmapheresis, where applicable; and

• (b) a complete record of

  • (i) all examinations, evaluations and reviews required by sections C.04.404, C.04.406, C.04.407 and C.04.411,

  • (ii) all tests carried out, and

  • (iii) all interviews conducted.

(2) Each donor record shall be cross-referenced to the units of human plasma associated with the donor.