Washington Fertility Center — FDA Warning Letter Findings

Failure of a responsible person to determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50(a)]. For example: a) The records for anonymous oocyte donor (b)(6), (b)(7)(C) (oocyte recovery date: (b)(6), (b)(7)(C) ) did not contain any documentation of the donor eligibility determination, which must be based on the results of mandatory donor screening and testing. b) The records for anonymous oocyte donor (b)(6), (b)(7)(C) (oocyte recovery date: (b)(6), (b)(7)(C) ) did not contain any documentation of the donor eligibility determination, which must be based on the results of mandatory donor screening and testing. c) The records for anonymous oocyte donor (b)(6), (b)(7)(C) did not contain documentation that the donor was determined “eligible.” The Summary of Records form for donor (b)(6), (b)(7)(C) included the name of the responsible person and the date, however the record did not document that the donor was determined eligible.

Regarding the failure to perform a physical examination for donors, you stated, “The provider shall accurately complete the physical examination. All forms shall immediately be entered into the Donor’s (b)(4) Medical Record.” During the current inspection, at least two donors were missing documentation of a physical examination.

In regard to establishing and maintaining a procedure for the release of an HCT/P from a donor whose specimen tests reactive for CMV, you stated, “Our procedure now mandates that the release of HCT/Ps from all semen donors who test positive for CMV shall have this information appear in materials accompanying the HCT/P so that the physicians can make an informed decision about the use of an HCT/P.” However, the current inspection documented that this procedure was still missing.

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)]. For example, the eligibility of anonymous oocyte donor (b)(6), (b)(7)(C) was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents. A specimen for communicable disease testing was collected from anonymous oocyte donor (b)(6), (b)(7)(C) on (b)(6), (b)(7)(C) . Donor (b)(6), (b)(7)(C) was determined eligible on December 7, 2021, but test results were not reported until December 9, 2021.

In regard to screening donors for ZIKV, you stated, “Current Zika Virus screening form for Oocyte Donors is currently updated periodically and includes all areas at risk for ZIKA according to the CDC including area within the United States.” Yet the current inspection documented that you are continuing to screen donors with the ZIKA Virus Screening Questionnaire for Oocyte Donors that lists “Current Zika Affected Areas” as of March 27, 2019. Your form was not updated at the time of your response and has not been updated since. The latest update on areas with Zika virus risk from the Centers for Disease Control and Prevention is dated October 11, 2022.

In the May 3, 2019, Untitled Letter, we noted that our review of your Procedure Manual for the Washington Fertility Center (effective 12/03/13), found requirements that were not in accordance with 21 CFR 1271. For example, the “Donor Testing” section for anonymous donors stated that a positive test for Hepatitis B Surface Antigen (HBsAg), “may not make the donor ineligible.” In accordance with 21 CFR 1271.80(d)(1), a donor whose specimen tests reactive on a screening test…

Failure to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part 1271.45-1271.90. “Establish and maintain” means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47(a)]. For example: a) Your procedures do not include the requirement to screen donors for risk factors for ZIKV. b) Your procedures do not include HBV NAT as a required test for relevant communicable disease agent and diseases. c) The current version of your Donor Medical History Interview Questionnaire , used to screen anonymous oocyte donors, was revised on November 17, 2021; however, the previous and obsolete questionnaire (revised on June 1, 2019), was the version included in the current procedure manual and was used to screen at least two donors.

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)]. FDA’s regulations at 21 CFR 1271.3(s) define the term “relevant medical records” to include a current donor medical history interview and a current report of the physical examination of a living donor. For example: a) The records for directed oocyte…

We want to remind you of the labeling requirements for HCT/Ps from donors for whom a donor eligibility determination is not required under 21 CFR 1271.90(a) and (b). Please note that such HCT/Ps must be labeled in accordance with 21 CFR 1271.90(c).

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, the donor specimen collected from anonymous oocyte donor (b)(6), (b)(7)(C) on (b)(6), (b)(7)(C) , was not tested for human immunodeficiency virus, type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) by the nucleic acid test (NAT) method. Oocytes were recovered from this donor on (b)(6), (b)(7)(C) .

Failure to establish and maintain a procedure governing the release of an HCT/P from a donor whose specimen tests reactive for cytomegalovirus (CMV) [21 CFR 1271.85(b)(2)]. For example, your procedures do not include how you will communicate test results of donors who are positive or reactive for CMV total antibody, including how the CMV test results should be communicated to the physician responsible for accepting the HCT/P. The deviations identified above are not intended…