Sperm Bank, Inc. dba Fertility Center of California - 694273 - 02/14/2025

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WARNING LETTER

CBER 25-694273

February 14, 2025

Dear Dr. Bastuba:

During an inspection of your firm, Sperm Bank, Inc. dba Fertility Center of California located at 6699 Alvarado Road, San Diego, CA, conducted between June 7, 2024 and June 12, 2024, the United States Food and Drug Administration (FDA) documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (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 deviations 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. These items of concern 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)). For example, the following repeat anonymous semen donors were not tested for West Nile Virus (WNV) using an FDA-licensed nucleic acid test (NAT) donor screening test at the time of the first donation that is recovered within the June 1st through October 31st testing period.

a. Semen was collected from donor (b)(6), (b)(7)(C) between (b)(6), (b)(7)(C). However, testing for WNV was performed on a specimen that was collected on (b)(6), (b)(7)(C). Donor (b)(6), (b)(7)(C) was determined eligible on 2/19/2024.
b. Semen was collected from donor (b)(6), (b)(7)(C) between (b)(6), (b)(7)(C). However, testing for WNV was performed on a specimen that was collected on (b)(6), (b)(7)(C). Donor (b)(6), (b)(7)(C) was determined eligible on 4/3/2024.

2) Failure to perform a complete donor screening procedure on a donor (21 CFR 1271.75). A complete donor screening includes reviewing the donor’s relevant medical records. Relevant medical records (21 CFR 1271.3(t)) include the donor medical history interview and a physical assessment of the donor. An abbreviated donor screening procedure, used to determine and document any changes in the donor’s medical history since the previous donation, may be used for repeat donors if you have performed a complete donor screening procedure within the previous six months. For example:

a. A complete donor screening procedure was performed on (b)(6), (b)(7)(C) for repeat anonymous semen donor (b)(6), (b)(7)(C), and semen was collected from this donor on (b)(6), (b)(7)(C). However, semen from this donation was released from quarantine on 5/20/2024 for distribution within the U.S. without a complete donor screening procedure within the previous six months.
b. A complete donor screening procedure was performed on (b)(6), (b)(7)(C) for repeat anonymous semen donor (b)(6), (b)(7)(C), and semen was collected from this donor between (b)(6), (b)(7)(C). However, semen from these donations was released from quarantine on 9/27/2023 for distribution within the U.S. without a complete donor screening procedure within the previous six months.
c. A complete donor screening procedure was performed on (b)(6), (b)(7)(C) for repeat anonymous semen donor (b)(6), (b)(7)(C), and semen was collected from this donor on (b)(6), (b)(7)(C). However, semen from this donation was released from quarantine on 12/4/2023 for distribution within the U.S. without a complete donor screening procedure within the previous six months.

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:

a. Semen was collected from donor (b)(6), (b)(7)(C) between (b)(6), (b)(7)(C). However, a specimen for communicable disease testing was collected from the donor on (b)(6), (b)(7)(C). Donor (b)(6), (b)(7)(C) was determined eligible on 2/19/2024.
b. Semen was collected from donor (b)(6), (b)(7)(C) between (b)(6), (b)(7)(C). However, a specimen for communicable disease testing was collected from the donor on (b)(6), (b)(7)(C). Donor (b)(6), (b)(7)(C) was determined eligible on 4/3/2024.
c. Semen was collected from donor (b)(6), (b)(7)(C) between (b)(6), (b)(7)(C). However, a specimen for communicable disease testing was collected from the donor on (b)(6), (b)(7)(C). Donor (b)(6), (b)(7)(C) was determined eligible on 5/9/2023 and 9/27/2023.
d. Semen was collected from donor (b)(6), (b)(7)(C) between (b)(6), (b)(7)(C). However, a specimen for communicable disease testing was collected from the donor on (b)(6), (b)(7)(C). Donor (b)(6), (b)(7)(C) was determined eligible on 5/17/2023.
e. Semen was collected from donor (b)(6), (b)(7)(C) between (b)(6), (b)(7)(C). However, a specimen for communicable disease testing was collected from the donor on (b)(6), (b)(7)(C). Donor (b)(6), (b)(7)(C) was determined eligible on 1/19/2023.

4) 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 procedures do not include WNV NAT as a required test for relevant communicable disease agents and diseases at the time of the first donation that is recovered within June 1st through October 31st of each year.

The deviations identified above are not intended to be an all-inclusive list of deficiencies 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, to include 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 25, 2024, providing a response to the 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:

• Regarding Observation 1, you state you have quarantined all semen vials for 6 months prior to release from donors that were identified to have incomplete donor eligibility determinations. Your response does not acknowledge that the remaining donor vials must remain in quarantine.
• Regarding Observation 2 and Observation 3, we acknowledge your revision to “Donor Acceptance Procedure” to include WNV NAT testing on the first semen collection between the period of June 1st through October 31st; however, your response does not address whether your procedures “Anonymous Sperm Donor Testing and Quarantine Protocol (Active Donor Protocol)” and “Anonymous Sperm Donor Acceptance Protocol (Potential Donor Protocol)” identified on the FDA 483 were updated.

As of May 20, 2024, FDA has determined Zika virus (ZIKV) is no longer a relevant communicable disease agent or disease (RCDAD) under FDA’s regulations. However, FDA Investigators identified donors that were not appropriately screened for ZIKV prior to May 20, 2024, in that the timeframe in your screening questions did not cover a 6-month time period.

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 (i.e., WNV NAT) and/or who were not appropriately screened for relevant communicable disease risk factors (i.e., ZIKV). 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 the violations addressed in this letter and prevent their recurrence. Failure to promptly correct these 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 the noted violations, including an explanation of how you plan to prevent these violations, 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