Conceive Fertility Center

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 determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1), (b), or (c) [21 CFR 1271.75(d)]. For example:

Passage 2

Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with 21 CFR 1271.75 and donor testing in accordance with 21 CFR 1271.80 and 21 CFR 1271.85 [21 CFR 1271.50(a)]. The eligibility of donors was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents. For example:

Passage 3

Failure to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor; or up to seven days before or after recovery [21 CFR 1271.80(b)]. For example,

Passage 4

Failure to include in the summary of records a statement noting the reason(s) for the determination of ineligibility in the case of an HCT/P from a donor who is ineligible based on screening and released under 21 CFR 1271.65(b) [21 CFR 1271.55(b)(4)]. For example, a review of the donor records collected during the inspection, revealed that at least 21 directed semen donors were determined “ineligible”, however, the summary of records does not state the reason for the determination of ineligibility.

Passage 5

Failure of the summary of records, required under 1271.55(a)(3), to contain a listing and interpretation of the results of all communicable disease tests performed [21 CFR 1271.55(b)(2)]. For example, your *SUMMARY OFRECORDS/DONOR ELIGIBILITY DETERMINATION- DONOR* form does not include a listing and interpretation of the results of specific testing for anti-HIV-1,anti-HIV-2, HIV-1 NAT, HBV NAT, HCV NAT, WNV NAT, anti-HTLV I/II, and anti-CMV (total IgG and IgM).