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WARNING LETTER

CBER 26-720249 

December 3, 2025 

Dear Dr. Fisch: 

During an inspection of your firm, Green Valley Fertility Partners located at 2950 W. Horizon Ridge, Henderson, NV, conducted between May 8, 2025, and May 14, 2025, the United States Food and Drug Administration (FDA) documented significant violations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (21 CFR) Part 1271 (21 CFR 1271) and issued under the authority of Section 361 of the Public Health Service Act, 42 U.S.C. § 264. 

The observations documented on the Form FDA-483, List of Inspectional Observations (FDA 483), were presented to and discussed with you at the conclusion of the inspection, and following FDA’s review, your violations include, but are not limited to, the following:

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)]. This includes testing for West Nile Virus (WNV) using an FDA-licensed Nucleic Acid Test (NAT) donor screening test for HCT/Ps recovered between June 1st and October 31st every year. For example, you recovered oocytes from anonymous donor OD, (b)(6), (b)(7)(C) on (b)(6), (b)(7)(C) and the Summary of Records documented the WNVNAT result as “Neg” on June 6, 2024; however, the donor testing results reported on June 6, 2024, do not list any results for WNV NAT. This donor was determined “eligible” on June 10, 2024.

We note that this is a repeat violation that was discussed with your firm during the FDA inspection conducted between April 11, 2022, and April 13, 2022. Specifically, oocytes were recovered from anonymous donor OD, (b)(6), (b)(7)(C) on (b)(6), (b)(7)(C), without being tested for WNV NAT. This donor was determined “eligible” on September 7, 2018. 

2) 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)]. Your Green Valley Fertility Partners Infectious Disease Questionnaire is used as a relevant medical record to determine donor eligibility. However, the questionnaire does not include screening for all relevant conditions and/or behaviors that increase a donor’s communicable disease risk. For example, the form is missing questions, timeframes, and/or deferral periods to assess a donor’s relevant communicable disease risk for the following:

a. Persons who have lived with (resided in the same dwelling) another person who has hepatitis B or clinically active (symptomatic) hepatitis C infection in the preceding 12 months. (Question 9 incompletely asks, “Have you in the preceding 12 months had close contact with a person who had clinically active hepatitis (e.g. living in the same household, sharing of kitchen and bathroom facilities)?”

b. Persons who have had sex in the preceding 12 months with any person who has injected drugs for non-medical reason in the preceding 5 years including intravenous, intramuscular, or subcutaneous injections.

c. Persons who have had a medical diagnosis or suspicion of WNV infection; a deferral period of 120 days following diagnosis or onset of illness, whichever is later, applies to such individuals.

d. Persons who have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.

e. Persons who have received a non-synthetic dura mater transplant.

f. Persons who have been diagnosed with Variant Creutzfeldt-Jakob Disease (vCJD).

g. Persons who have a history of CJD in a blood relative.

h. Persons who have received any transfusion of blood or blood components in France between 1980 and the present.

i. Persons who have dementia, demyelinating disease of the central nervous system or other neurological disease of unknown etiology.

j. Persons who are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996.

3) 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, directed oocyte donor (b)(6), (b)(7)(C) answered "yes" to Question #19 on the Green Valley Fertility Partners Infectious Disease Questionnaire, "Have you lived cumulatively for 5 years or more in Europe from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996)?" Donor (b)(6), (b)(7)(C) was determined “eligible” on October 10, 2022, and August 8, 2022.

4) 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 two oocyte donors was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents and/or the completion of the physical examination. For example:

a. Directed oocyte donor (b)(6), (b)(7)(C) was determined “eligible” on January 30, 2024. However, the physical examination was not completed until (b)(6), (b)(7)(C), and the results of donor testing were not received until January 31, 2024.

b. Anonymous oocyte donor OD, (b)(6), (b)(7)(C) was determined “eligible” on September 5, 2022. However, the physical examination and the Green Valley Fertility Partners Infectious Disease Questionnaire were not completed until (b)(6), (b)(7)(C).

5) Failure to omit the donor’s name and other personal information on the accompanying records [21 CFR 1271.55(c)]. For example, the names and birthdates of anonymous oocyte donors are included on the Summary of Records, which is considered an accompanying record as described in 21 CFR 1271.55(a).

6) Failure to affix a distinct identification code to the HCT/P container, e.g., alphanumeric, that relates the HCT/P to the donor and all records pertaining to the HCT/P and, except in the case of autologous donations, directed reproductive donations, or donations made by first-degree blood relatives, does not include an individual’s name, social security number, or medical record number [21 CFR 1271.55(a)(1)]. For example, your firm identifies anonymous oocyte donors with “OD” followed by their first name on the Summary of Records, which is considered an accompanying record as described in 21 CFR 1271.55(a).

The violations identified above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment complies with all applicable federal regulations. You are responsible for reviewing your firm’s operations, including firms within the same organization, as a whole to ensure that you are in compliance with the law. 

Additional information regarding the regulation of HCT/Ps is available at:

• https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products
• https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissue-guidances
• FDA Workshop for the Reproductive Tissue Industry - Sept 29 and Oct 1, 2020 -09/29/2020 - 10/01/2020 | FDA

Please note that if you still have oocytes and/or semen in storage from donors whose screening and/or testing was not completed in accordance with 21 CFR Part 1271, FDA considers the donor eligibility determinations to be incomplete for these donors. For example, this includes donors who were not appropriately tested for relevant communicable disease agents and diseases and/or who were not appropriately screened for relevant communicable disease risk factors. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine.

Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may request an exemption or alternative from a requirement in Subpart C, 21 CFR Part 1271, as specified in 21 CFR 1271.155. Additional information can be found at Exemptions and Alternatives | FDA. The email address for submissions is HCTPExemptions@fda.hhs.gov.

Please note that 21 CFR 1271.155 requires that you provide justification for use of HCT/Ps from these donors, as well as information on how you have mitigated the risk consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases. Before any of these HCT/Ps can be removed from quarantine, the request must be granted by FDA.

If you still have embryos in storage for which the donor eligibility requirements under 21 CFR 1271, Subpart C are not met, please note that FDA considers the donor eligibility determinations to be incomplete for these donors. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine. Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may release these HCT/Ps from quarantine (21 CFR 1271.90(b)) provided they are labeled in accordance with the applicable regulations at 21 CFR 1271.90(c).

You should take prompt action to correct any violations addressed in this letter and prevent their recurrence. Failure to promptly correct any violations may result in regulatory action being initiated by FDA without further notice.

We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct any violations, including an explanation of how you plan to prevent them, or similar violations, from occurring again. Additionally, include any documentation necessary to show that correction has been achieved. If you believe that your products are not in violation of the law, include your reasoning and any supporting information for our consideration. If you cannot complete all corrective actions within fifteen (15) working days, please explain the reason for your delay and the timeframe within which the remaining corrections will be completed.

Your written response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, WO71-G112, Silver Spring, MD 20993-0002. Please also email your response to CBERDCMRecommendations@fda.hhs.gov.

If you have any questions regarding this letter, please contact CBER’s Division of Case Management at CBERDCMRecommendations@fda.hhs.gov. Please be advised that only written communications are considered official.

Sincerely,
/S/

Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research