Cooper Institute

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to test a specimen from an anonymous or directed reproductive donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. For example:

Passage 2

Failure of a responsible person to determine and document the eligibility of a donor of reproductive cells or tissue based on the results of donor screening and testing [21 CFR 1271.50(a)]. For example, the records for the following anonymous oocyte donors did not contain documentation of the donor eligibility determination, including the name of the responsible person who made the determination, the date of the determination, and documentation that the donor was determined “eligible:”