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WARNING LETTER

The New Hope Center for Reproductive Medicine MARCS-CMS 658251 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Reference #:
23-658251
Product:
Biologics

Recipient:
Recipient Name
Robin L. Poe-Zeigler, MD
Recipient Title
Medical Director
The New Hope Center for Reproductive Medicine

448 Viking Drive, Suite 100
Virginia Beach, VA 23452
United States

Issuing Office:
Division of Biological Products Operations I

United States


WARNING LETTER

06/27/2023

Dear Dr. Poe-Zeigler:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm, The New Hope Center for Reproductive Medicine located at 448 Viking Drive, Suite #100, Virginia Beach, VA, between December 8, 2022 and January 23, 2023. During the inspection, an FDA Investigator 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. The items of concern 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)]. 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. During the inspection, your firm stated that donors complete a questionnaire online via your firm’s website which was the only medical screening questionnaire presented to the donors. However, our review of your anonymous and directed donor records since May2021, found that the donor records were missing this questionnaire, to include documentation of most, if not all, required questions that screen for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases (RCDADs). For example:

i. Directed oocyte donor (b)(6), (b)(7)(C) was determined eligible on 3/5/2022 and oocytes were recovered from the donor on (b)(6), (b)(7)(C);

ii. Directed oocyte donor (b)(6), (b)(7)(C) was determined eligible on 2/8/2022 and oocytes were recovered from the donor on (b)(6), (b)(7)(C);

iii. Anonymous oocyte donor (b)(6), (b)(7)(C) was determined eligible on 11/14/2021 and oocytes were recovered from the donor on (b)(6), (b)(7)(C);

iv. Directed semen donor (b)(6), (b)(7)(C) was determined eligible on 10/1/2021 and semen was recovered from the donor on (b)(6), (b)(7)(C); and

v. Anonymous oocyte donor (b)(6), (b)(7)(C) was determined eligible on 7/20/2021 and oocytes were recovered from the donor on (b)(6), (b)(7)(C).

b. Our review of donor records for anonymous oocyte donor (b)(6), (b)(7)(C) found that oocytes were recovered from the donor on (b)(6), (b)(7)(C); however, a physical examination was documented on (b)(6), (b)(7)(C), more than (b)(4) prior to the donation.

2) 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 for oocyte donors, up to 30 days before recovery or up to seven days after recovery [21 CFR 1271.80(b)]. For example, a specimen for communicable disease testing was collected from anonymous oocyte donor (b)(6), (b)(7)(C) on (b)(6), (b)(7)(C). However, oocytes were recovered from the donor on (b)(6), (b)(7)(C).

3) Failure to establish and maintain procedures for all steps performed in testing, screening, and 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 (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47 (a)]. For example, your firm’s procedures do not include all steps and risk factors for donor screening, all required tests and timeframes for donor testing, the steps and requirements for determining donor eligibility, criteria that would make a donor ineligible, and all additional relevant requirements in Subpart C of 21 CFR Part 1271.

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 is in compliance with all applicable requirements of the federal regulations. You are responsible for reviewing your firm’s operations as a whole to ensure that you are in compliance with all applicable FDA regulatory requirements.

We acknowledge receipt of your letter dated 2/3/2023, in response to FDA’s inspectional observations. We have reviewed the corrective actions outlined in the response, and we have determined that the response is inadequate to address our concerns. We have the following comments regarding your FDA 483 response.

In response to Observation 1, you submitted a new Donor Medical History Interview Form that includes screening questions to evaluate donors for risk factors for relevant communicable disease agents and diseases. However, we note that the form is missing questions that evaluate donors for certain risk factors or the questions as written do not adequately screen donors for that specific risk factor. Your form should be updated to include this information, as follows:

1. The form does not include a question regarding persons who have had a past diagnosis of clinical, symptomatic viral hepatitis after their 11th birthday, unless evidence from the time of illness documents that the hepatitis was identified as being caused by hepatitis A virus, Epstein-Barr virus (EBV), or cytomegalovirus (CMV).

2. Question 12 asks about a medical diagnosis of West Nile virus (WNV) infection but does not ask about a suspicion of WNV.

3. The form does not include a question that screens donors for testing positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.

4. Question 28 asks about travel to an area with active Zika virus (ZIKV) transmission in the past 6 months, but should ask about residence in, or travel to, an area with an increased risk for ZIKV transmission.

5. Question 29 asks about sex with a male who has been diagnosed with ZIKV but should ask whether the donor has had sex with a person who has been diagnosed with ZIKV in the past 6 months.

In response to Observations 1 through 5, you stated that you have re-screened donors who were not evaluated for all required RCDAD risk factors, updated Summary of Records forms, and marked as “ineligible” donors who were not tested in accordance with regulatory requirements. Please note that all your donors were missing screening for multiple risk factors for RCDADs at the time of donation. Additionally, certain donors were not tested in accordance with 21 CFR 1271 or were missing documentation of a current physical examination.

As required under 21 CFR 1271.50(a), you must 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 1271.85. Donors whose screening and/or testing were not performed in compliance with the aforementioned regulatory citations cannot be determined “eligible” or “ineligible.” FDA considers the donor eligibility determination to be incomplete, and all HCT/Ps remaining in storage from these donors must be stored under quarantine. As this affects all your donors, we have provided at the end of the letter information regarding exemption requests and labeling should you need to remove any of these HCT/Ps from storage.

In response to Observation 6, we acknowledge that you have revised specific sections of The New Hope Center Donor Oocyte Program procedure, but your procedures remain deficient for the reasons set forth below. Please note that this list is not all-inclusive. It continues to be your responsibility to ensure that your establishment is in full compliance with 21 CFR 1271 at all times.

We recommend that you review your firm’s procedures and make the necessary changes to ensure they include all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements in accordance with 21 CFR 1271 of Subpart C - Donor Eligibility.

1. Your response to Observation 6 states, “We have added specific testing into our SOP’s (sic) that instructs the tests needed to be performed are HIV, Hep B, Hep C, HTPE, Creutzfeldt Jacob (sic) Disease, and communicable disease risks associated with Xenotransplantation.” We note that screening donors for communicable disease risks of Creutzfeldt-Jakob Disease (CJD) and xenotransplantation is done through donor history questions that are part of the screening process. There are currently no tests that can evaluate a donor’s risk for CJD or xenotransplantation.

2. Your procedure includes testing for ZIKV under the “Final Serology Testing” section. Please note that there are currently no available tests for ZIKV that are considered appropriate for preventing transmission of ZIKV through HCT/Ps.

3. The procedure is still missing many of the requirements in Subpart C of 21 CFR 1271.Under 21 CFR 1271.47(a), 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 the subpart.

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 screened using a donor history questionnaire that was missing required screening questions, donors who were missing a physical examination, and donors who were not tested for relevant communicable disease agents in accordance with regulatory requirements. 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: http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/RegulationofTissues/Exempt ionsandAlternativeProcedures/default.htm). 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 Part 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 the 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. If you believe that your products are not in violation of the law, include your reasoning and any supporting information for our consideration. Additionally, include any documentation necessary to show that correction of any of the above-noted violations has been achieved. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed.

Your response should be sent to LT Yvesna Blaise, Compliance Officer at the following email address: Yvesna.blaise@fda.hhs.gov. If you have any questions, please contact LT Blaise at 973-331-4970 or via e-mail.

Sincerely,
/S/

Michael W. Roosevelt
Program Division Director
Office of Biological Products Operations – Division 1

 
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