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WARNING LETTER

CBER 26-722459

January 27, 2026

Dear Dr. Haas:

During an inspection of your firm, Conceive Fertility Center located at 7515 Greenville Ave Ste 1030, Dallas, TX 75231, conducted between June 6, 2025, and June 13, 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 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 firm’s Donor Medical History Interview Form is used as a relevant medical record to determine donor eligibility. From January 1, 2022, through June 12, 2025, your firm used this form to screen approximately 61 anonymous oocyte donors, 40 directed oocyte donors, and 79 directed semen donors. However, your form does not include screening for all conditions and/or behaviors that increase a donor’s relevant communicable disease risk. The form is missing questions, timeframes, and/or deferral periods to assess a donor’s relevant communicable disease risk:

a. Question 5 states, “Have you had sex in the preceding 12 months with any person described in the previous 4 items in this section or with any person known or suspected to have HIV infection, clinically active hepatitis B infection, or hepatitis C infection?” To adequately and appropriately reduce the risk of transmission of these diseases, the question needs to ask about hepatitis B infection (both active and inactive) and clinically active (symptomatic) hepatitis C infection.

b. Question 8 states, “Have you had close contact within 12 months preceding donation with another person having clinically active viral hepatitis (e.g., living in the same household, where sharing of kitchen and bathroom facilities occurs regularly)?” The question needs to ask whether persons 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.

c. Question 9 states, “Have you had a tattoo or body piercing in the last 12 months in which instruments were shared?” The question needs to also ask whether sterile procedures were not used.

d. Persons who have had a medical diagnosis or suspicion of West Nile Virus (based on symptoms and/or laboratory results or confirmed WNV viremia) need to be deferred for 120 days following diagnosis or onset of illness, whichever is later. You do not include “suspicion” in your form or equivalent terminology to adequately screen for this illness.

e. Your form fails to screen for 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.

f. Your form fails to screen for persons who have been treated for or had syphilis within the preceding 12 months.

g. Your form fails to adequately screen for 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. Without “cumulatively” or similar language the question is under-inclusive.

h. Your form fails to screen for persons who have received any transfusion of blood or blood components in France between 1980 and the present.

2) 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:

a. Directed semen donor (b)(6) answered "yes" to Question #26 on the Spanish version of the Donor Medical History Interview Form, “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) was determined “eligible” on April 30, 2025.

b. Directed semen donor (b)(6) answered "yes" to Question #1 on the Donor Medical History Interview Form, "(Men Only) Have you had sex with another man in the preceding five years?" Donor (b)(6) was determined “eligible” on April 12, 2024.

3) 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:

a. Directed oocyte donor (b)(6) was determined “eligible” on February 20, 2025, but the results of donor testing were not received until February 22, 2025.

b. Anonymous oocyte donor (b)(6), Donor (b)(6) was determined “eligible” on September 28, 2024, but the results of donor testing were not received until September 30, 2024.

4) 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,

a. Semen was collected from directed donor (b)(6) on (b)(6). However, a specimen for communicable disease testing was collected from the donor on (b)(6). Donor (b)(6) was determined “eligible” on December 19, 2024.

b. Semen was collected from directed donor (b)(6) on (b)(6). However, a specimen for communicable disease testing was collected from the donor on (b)(6). Donor (b)(6) was determined “ineligible” on October 2, 2023.

5) 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. 

6) 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).

7) 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, your Standard Operating Procedure (SOP), Office Screening of Patients Donating Human Cells (Oocytes and Sperm), does not contain donor eligibility procedures describing requirements that must be met to determine a donor as eligible or ineligible. We note that this is a repeat violation that was discussed with your firm during the FDA inspection conducted between October13, 2021, and October 15, 2021.

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. 

We acknowledge receipt of your letter, dated June 24, 2025, providing a response to FDA’s inspectional observations. We have reviewed your response, and we have determined that the response is inadequate to address our concerns. We have the following comments regarding your FDA 483 response:

1) Regarding Observation 2, your response did not address whether there are HCT/Ps still in storage from donors that were not screened and/or tested in accordance with 21 CFR 1271.

2) Regarding Observation 3, we acknowledge the implementation of your new SOP, Screening and Eligibility Determination for Sperm Donors Regarding Cytomegalovirus (CMV) (Effective Date: 06/17/2025). However, the SOP does not include how the CMV test results will be communicated to the physician responsible for accepting the HCT/P so that they may rely on the information to make informed decisions about the use of an HCT/P in a particular recipient's situation. 

3) Regarding Observation 4, we acknowledge your revision to SOP, Office Screening of Patients Donating Human Cells (Oocytes and Sperm) (Revised Date: 06/24/2025), to include requirements that must be met to determine a donor as eligible or ineligible and departures from procedures. Our review of your procedure found the following:

a. Your procedure does not specify anti-HBc and WNV NAT as required testing.

b. Section 3, “Medical History Evaluation,” states that if donors respond “yes” to a question on your Donor Medical History Interview Form (DMHIF), “Further investigation with laboratory testing may be needed before the physician determines the patient can be considered eligible to donate tissue.” Section 6, “Donor Eligibility Determination,” states that if donors respond “yes” to a question on your DMHIF, and “… it is determined that the risk of a communicable disease is negligible, the donor may still pass.” In accordance with 21 CFR 1271.75(d)(1), 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 paragraphs (a)(1), (b), or (c) must be determined to be ineligible. This applies to both anonymous and directed donors.

c. Section 6, “Donor Eligibility Determination,” regarding test results states, “If any of the testing is positive, a provider must determine if there is an active infection (donor would be ineligible in that case), or if there is a previously treated infection that continues to show positive for the test in question.” In accordance with 21 CFR 1271.80(d)(1), a donor whose specimen tests reactive on a screening test for a communicable disease agent in accordance with 21 CFR 1271.85, except for a donor whose specimen tests reactive on a non-treponemal screening test for syphilis and negative on a specific treponemal confirmatory test, must be determined to be ineligible. This applies to both anonymous and directed donors.

d. Section 6, “Donor Eligibility Determination,” allows for donors who test reactive for Chlamydia trachomatis or Neisseria gonorrhea to be reconsidered with a negative test-of-cure and a 3-month waiting period after completion of treatment. However, evidence needs to be presented that the treatment occurred more than 12 months ago and was successful.

Finally, we have the following additional comments regarding your firm's operations:

• Section 6 of your SOP, Office Screening of Patients Donating Human Cells (Oocytes and Sperm) (Revised Date: 06/24/2025), states that the “Summary of Records/Donor Eligibility Determination Form” is completed with the “Eligible” or “Ineligible” status. There are two locations on this form where your firm documents and dates the donor eligibility determination. The dates do not match for multiple donors.
• Sections III (ELIGIBILITY) and IV (LABELING) of the “Summary of Records/Donor Eligibility Determination Form” includes checkboxes for “ELIGIBLE.” However, “ELIGIBLE” was also checked under Section IV for several directed donors who were determined “INELIGIBLE” under Section III. In addition, the symbols listed in Section IV do not include the Biohazard legend shown in 21 CFR 1271.3(h).

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 which includes using previous versions of donor history questionnaires (e.g., non-English versions) that did not screen for all conditions and/or behaviors that increase a donor’s relevant communicable disease risk. 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