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WARNING LETTER

Strong Fertility Center MARCS-CMS 593262 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Biologics

Recipient:
Recipient Name
Kathleen Hoeger, MD
Recipient Title
Director of Tissue Bank Operations
Strong Fertility Center

500 Red Creek Drive, Suite 220
Rochester, NY 14623-4285
United States

Issuing Office:
Office of Biological Products Operations – Division I

555 Winderley Place, Suite 200
Maitland, FL 32751
United States


WARNING LETTER

October 29, 2019       
Warning Letter # OBPO 20-593262

 

Dear Dr. Hoeger:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Strong Fertility Center, located at 500 Red Creek Drive, Suite 220, Rochester, NY, from August 12, 2019 through August 16, 2019.  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, 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 donor of reproductive cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. Living HCT/P donors should be tested 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, the following donors were not tested for WNV NAT:

  1. Oocytes were recovered from anonymous donor (b)(6) on October 26, 2018. The donor was determined eligible on November 19, 2018.
  2. Oocytes were recovered from anonymous donor (b)(6) on October 19, 2018 and August 18, 2017. The donor was determined eligible on November 19, 2018 and August 7, 2017, respectively.
  3. Oocytes were recovered from directed donor (b)(6) on June 13, 2018. The donor was determined eligible on June 28, 2018.
  4. Oocytes were recovered from anonymous donor (b)(6) on June 20, 2018. The donor was determined eligible on June 28, 2018.
  5. Oocytes were recovered from anonymous donor (b)(6) on June 18, 2018. The donor was determined eligible on June 28, 2018.
  6. Oocytes were recovered from anonymous donor (b)(6) on August 10, 2017. The donor was determined eligible on July 28, 2017.
  7. Oocytes were recovered from anonymous donor (b)(6) on September 15, 2017. The donor was determined eligible on August 31, 2017.
  8. Oocytes were recovered from anonymous donor (b)(6) on August 25, 2017. The donor was determined eligible on August 12, 2017.

2.    Failure to determine an HCT/P donor to be eligible prior to implantation, transplantation, infusion, or transfer of the HCT/P(s) [21 CFR 1271.45(c)]. For example, the following donors were determined eligible after the transfer of HCT/P(s) to the recipient(s):

     a. Anonymous oocyte donor (b)(6) was determined eligible on April 22, 2019, however HCT/Ps from the donor had already been transferred to the recipient on April 15, 2019.

     b. Anonymous oocyte donor (b)(6) was determined eligible on February 14, 2019, however HCT/Ps from the donor had already been transferred to the recipient on February 5, 2019.

     c. Anonymous oocyte donor (b)(6) was determined eligible on November 19, 2018 and January 28, 2019, however HCT/Ps from the donor had already been transferred to the recipients on October 24, 2018 and January 23, 2019, respectively.

    d. Anonymous oocyte donor (b)(6) was determined eligible on June 28, 2018, however HCT/Ps from the donor had already been transferred to the recipient on June 23, 2018.

     e. Anonymous oocyte donor (b)(6) was determined eligible on May 30, 2018 and November 19, 2018, however HCT/Ps from the donor had already been transferred to the recipients on May 22, 2018 and November 7, 2018, respectively.

3.    Failure to screen a donor of reproductive cells or tissue by a 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)]. For example:​​​​​​​

a.  Your firm’s Donor Medical/Social History Interview Form (Revised: 10/2016) is used as a relevant medical record to determine donor eligibility. However, the form does not include screening for all conditions and/or behaviors that increase a donor's relevant communicable disease risk. For example, questions for the following risk factors for relevant communicable disease agents and diseases are missing from your screening forms:

      1. Persons who have had a suspicion of WNV infection.
      1. 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.
      1. 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. bases in Northern Europe for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe for 6 months or more cumulatively from 1980 through 1996.
      1. Persons who received any transfusion of blood or blood components in France between 1980 and the present.
      1. Persons who resided in an area with an increased risk for ZIKV transmission within the past 6 months.
      1. Persons who have had sex within the past 6 months with a person with a medical diagnosis of ZIKV in the past 6 months or who resided in an area with an increased risk for ZIKV transmission within the past 6 months.

​​​​​​​b.  Directed oocyte donor (b)(6) was determined eligible on June 28, 2018. However, the donor failed to answer all required donor screening questions on the “Donor Medical/Social History Interview Form.” Page three of the form was left blank.

In addition, during our review of several procedures collected during the inspection of your establishment, we noted that they may not include all the steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of Subpart C - Donor Eligibility. We recommend that you review all of your firm’s procedures to ensure they include testing and screening for all required relevant communicable disease agents, documentation of donor eligibility determinations, your firm’s criteria for determining whether a donor is eligible or ineligible, and any additional steps you perform in accordance with 21 CFR 1271.

The deviations identified above are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that your establishment fully complies with the law. You are responsible for reviewing your firm’s operations as a whole to assure that you are in compliance with all statutory and regulatory requirements.

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, donors who were not tested for WNV, donors who were screened using a donor history questionnaire that was missing required screening questions, and donors who were not screened for risk factors for 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 oocytes or semen 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: https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/exemptions-and-alternatives). 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 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 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 the following address: U.S. Food and Drug Administration, Cherlita Honeycutt, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215 or emailed to Cherlita.Honeycutt@fda.hhs.gov. If you should have any questions, please contact Cherlita Honeycutt, Compliance Officer, at (410) 779-5412 or via email.

Sincerely,

/S/

Elizabeth A. Waltrip

Program Division Director

Office of Biological Products Operations – Division I