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.
- SOR/78-545, s. 1
- SOR/85-1022, s. 13
- SOR/97-12, s. 61
- Date modified: