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WARNING LETTER
CBER 26-722521

January 29, 2026

Dear Dr. Ramirez:

During an inspection of your firm, Central Coast Multispecialty Medical Group, Inc., located at 9833 Blue Larkspur Lane, Monterey, CA, conducted between May 13, 2025, and May 16, 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’srelevant medical records for risk factors for, and clinical evidence of, relevantcommunicable disease agents and diseases [21 CFR 1271.75(a)(1)]. Your firm’sDonor Eligibility Questionnaire and Donor Medical History Interview Form areused as relevant medical records to determine donor eligibility. However, yourforms do not include screening for all conditions and/or behaviors that increase adonor’s relevant communicable disease risk. For example, the Donor EligibilityQuestionnaire form submitted with your FDA 483 response is missing questions,timeframes, and/or deferral periods to assess a donor’s relevant communicabledisease risk for the following:

a. Question 5 fails to screen for persons who have had sex in the preceding 12 months with any person who has had sex with a man who has had sex with another man in the preceding 5 years, persons with hepatitis B infection (both active and inactive) or clinically active (symptomatic) hepatitis C infection, persons who have injected drugs for a non-medical reason in the preceding 5 years, including intravenous, intramuscular, or subcutaneous injections, and persons who have engaged in sex in exchange for money or drugs in the preceding 5 years.

b. Question 8 states, “Have you within the past 12 months of donation undergone tattoing [sic], ear piercing, or body piercing in which shared instruments are known to have been used.” The question needs to also ask whether sterile procedures were not used.

c. Question 11 states, “Have you had a recent smallpox vaccination (vaccinia virus) in the last 21 days?” To adequately and appropriately reduce the risk of transmission of this disease, the question needs to ask about smallpox vaccination (vaccinia virus) in the preceding 8 weeks.

d. Question 13 states, “Have you had a medical diagnosis of West Nile Virus Infection within the last 120 days (including diagnosis based on symptoms and laboratory results, or confirmed WNV viremia)?” You do not include “suspicion” in your form or equivalent terminology to adequately screen for this illness.

e. Your form fails to adequately screen for persons who have spent 3 months or more cumulatively in the UK between 1980 and 1996. Without “cumulatively” or similar language the question is under-inclusive.

f. 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.

g. Your form fails to screen for persons who spent 5 years or more cumulatively in Europe from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996).

h. Your question 29 states, “Have you had close contact within 12 months preceding donation with another person having clinically active viral hepatitis?” To adequately and appropriately reduce the risk of transmission of this disease, the question needs to also ask about 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. 

i. 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.

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, directed semen donor (b)(6) answered "yes" to question 1 on your 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 May 9, 2025.

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 donor (b)(6) was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents. For example, directed semen donor (b)(6) was determined “eligible” on May 9, 2025, but the results of donor testing for Chlamydia trachomatis, Neisseria gonorrhea, and HIV/HCV/HBV NAT were not received until May 10, 2025.

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

We acknowledge receipt of your letter, dated May 28, 2025, 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:

1) We acknowledge the revisions made to your Donor Eligibility Questionnaire submitted with your response. However, our review of this questionnaire identified additional deficiencies as outlined in this letter.

2) Regarding Observations 1 and 2, your response does not address the required labeling in accordance with 21 CFR 1271.65(b)(2). All donors, except as provided under 21 CFR 1271.90, are required to be screened 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)) and tested for relevant communicable diseases (21 CFR 1271.80). Please note, an HCT/P from a donor who has been determined to be ineligible, based on the results of required testing and/or screening, is not prohibited by Subpart C from use for implantation, transplantation, infusion, or transfer if the HCT/P consists of reproductive cells or tissue from a directed reproductive donor as defined in 21 CFR 1271.3(l).

3) Regarding Observation 3, you stated “The policies and procedures that are in place in regards to our treatment of Donor patients is verbally transmitted through training and continuous guidance, and we do not rely on the Donor policy book for reference or use. It is merely there to be compliant.” Please be advised, you must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of 21 CFR Part 1271, Subpart C. Establish and maintain means define, document (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis.

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 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