Zhang Medical P.C. dba New Hope 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) [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 three anonymous oocyte 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 of a responsible person to determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50(a)]. For example:

Passage 4

Failure to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)(1)]. For example:

Passage 5

Failure to determine as ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent for which testing is required under 21 CFR 1271.85 [21 CFR 1271.80(d)(1)]. For example, a specimen for communicable disease testing collected on **(b)(6)**, from directed oocyte donor **(b)(6)**, tested reactive on a screening test for the antibody to hepatitis B core antigen (anti-HBc). The donor was not determined ineligible, as required

Passage 6

Failure to collect donor specimens for testing for relevant communicable diseases at the time of recovery of the cells or tissue from the donor; or for oocyte donors, within 30 days prior to oocyte recovery or up to seven days after recovery [21 CFR 1271.80(b)]. For example, a specimen for communicable disease testing was collected from directed oocyte donor **(b)(6)**, on **(b)(6)**. However, the oocytes were recovered from the donor on **(b)(6)**.

Passage 7

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, the following directed oocyte donors were determined ineligible without documentation noting the reason(s) for ineligibility: