Food and Drug Regulations

C.04.415 A fabricator shall place source plasma in a container

• (a) in respect of which a medical device licence has been issued under the Medical Devices Regulations for the purpose of collecting and storing plasma;

• (b) that permits visual, electronic or automated inspection of the plasma;

• (c) that has been visually inspected at the plasmapheresis session and found to be intact; and

• (d) that has not been previously used for any purpose, including holding source plasma from the same donor.