Food and Drug Regulations

C.04.418 (1) A fabricator shall inspect each container of source plasma to determine if the container and its label are intact and if there are any indications that the source plasma has been subject to thawing.

(2) The fabricator shall dispose of the source plasma if the inspection shows that

• (a) the container is defective or damaged to the extent that it does not provide protection against external factors that could result in deterioration or contamination of the source plasma;

• (b) the unique identifier assigned to the source plasma is missing or illegible;

• (c) any information required under paragraphs C.04.416(2)(b) to (i) is missing or illegible, unless the missing or illegible information can be retrieved from the fabricator’s records; or

• (d) the source plasma has been subject to thawing.