Food and Drug Regulations

Version of section C.04.428 from 2006-03-22 to 2006-12-13:

  •  (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.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 13;
  • SOR/97-12, s. 61.
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