WARNING LETTER
Montgomery Women's Medical Center PC dba Montgomery Fertility Center
MARCS-CMS 607345 —
May 14, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
20-607345
Product:
Biologics
Recipient:
Recipient Name
Oluyemisi 0. Famuyiwa, M.D.
Recipient Title
Medical Director
Montgomery Women's Medical Center PC dba Montgomery Fertility Center
3202 Tower Oaks Blvd., Ste. 370
Rockville
,
MD
20852-4296
United States
Issuing Office:
Office of Biological Products Operations - Division 1
United States
WARNING LETTER
May 14, 2020
Dear Dr. Famuyiwa:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Montgomery Fertility Center, located at 3202 Tower Oaks Blvd., Ste. 370, Rockville, MD, between January 8 and January 21, 2020. 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 lnspectional Observations, 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 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.SS(a)]. For example:
a. The donor specimens collected from anonymous oocyte donors
(b)(6)
,
(b)(6)
, and
(b)(6)
were not tested for human immunodeficiency virus, type 1 (HIV-I), hepatitis C virus (HCV), and hepatitis B virus (HBV) by the nucleic acid test (NAT) method.
b. 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 31 st every year. For example, three anonymous oocyte donors (
(b)(6)
, and
(b)(6)
) were not tested for WNV during that time period.
2. 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)(l)]. For example:
a. Your donor medical history questionnaire,
Donor Cycle Form 2 Donor Questionnaire
, 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:
i. Persons who had a medical diagnosis of Zika Virus (ZIKV) in the past 6 months. Your questionnaire asks only about the past 120 days.
ii. Persons who resided in an area with an increased risk for ZIKV transmission within the past 6 months. Your questionnaire asks only about the past 120 days and does not include all areas at risk for ZIKV according to the Centers for Disease Control and Prevention.
iii. 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. Your questionnaire asks only about the past 120 days.
b.
Donor Cycle Form 2 Donor Questionnaire
for anonymous oocyte donors
(b)(6)
, and
(b)(6)
were missing documentation of answers to some of the ZIKV risk screening questions.
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 assure that you are in compliance with all of the FDA regulatory requirements.
We acknowledge receipt of your letter, dated January 27, 2020, which provides a response to the Form FDA 483, List of lnspectional Observations. We have reviewed the corrective actions outlined in your response and we have the following comments:
1. In response to Observation 1, we acknowledge that you have added to your procedures the requirement to test donors for HIV-1/HCV/HBV NAT and WNV. However, please note that for donors who were not tested in accordance with regulatory requirements, the donor eligibility determinations for these donors are considered incomplete. We have included at the end of the letter additional information should you still have HCT/Ps in storage for these donors and wish to use them in the future. Additionally, we note that your procedures and
Donor Cycle Form 1: FDA Disease Screen for Anonymous Oocyte Donors
include testing for Zika virus. Please note there are currently no available tests for ZIKV that are considered appropriate for preventing transmission of ZIKV through HCT/Ps.
2. In response to Observation 2, we acknowledge that you revised the
Donor Cycle Form 2 Donor Questionnaire, Rev 1-21-2020
to include screening for all required risk factors for relevant communicable disease agents and diseases. However, we note that your
revisions to question 14 have omitted information 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. Your donor screening procedures should also be updated to include this information.
3. In response to Observation 5, you submitted a revised
Donor Cycle Form 1: FDA Disease Screen for Anonymous Oocyte Donors
form for documentation of the donor eligibility determination. Please note that while you may use this form to record the dates of donor screening and the specimen collection date for testing for relevant communicable diseases, you cannot perform a donor eligibility determination until the results of relevant communicable disease testing have been received by your establishment. Therefore, you must not determine and document the donor eligibility determination before the report date from your testing lab.
Please note that if you still have oocytes 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 tested for WNV NAT and/or HIV/HCV/HBV NAT, donors who were screened using a donor history questionnaire that was missing required screening questions, and donors who were not appropriately screened for ZIKV risk factors. 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 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/TissueProducts/RegulationofTissues/ExemptionsandAlternativeProcedures/default.htm). Please note that 21 CFR 1271.155 requires that you provide justification for use ofHCT/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.
It appears you still have embryos in storage for which the donor eligibility requirements under part 1271, Subpart Care 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 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 response should be sent to either of the following address: Valerie Grecek-Trinh, U.S. Food and Drug Administration, Office of Biological Products Operations- Division 1,400 W. Bay St. Room 401, Jacksonville, FL 32202 or Colleen Aspinwall, U.S. Food and Drug Administration, Office of Biological Products Operations - Division 1, 1515 N. Federal Highway, Ste., 111, Boca Raton, FL 33432. Your response may also be emailed to Colleen.Aspinwall@fda.hhs.gov or Valerie.Grecektrinh@fda.hhs.gov. lfyou should have any questions, please contact Colleen Aspinwall, Compliance Officer, at
(561) 416-1065
, ext. 1105 or Valerie Grecek-Trinh, Compliance Officer, at
(904) 353-4560
, ext. 118 or via email.
Sincerely,
/S/
Elizabeth A. Waltrip
Program Division Director
Office of Biological Products Operations - Division 1
Content current as of:
05/26/2020
Regulated Product(s)
Biologics