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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Gramercy Fertility Services 5/18/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433 

 

May 18, 2012
 
WARNING LETTER NYK 2012-20
 
 
VIA UNITED PARCEL SERVICE
 
Dr. Khaled Zeitoun, Medical Director
Carlo Acosta, Tissue Bank Director
Gramercy Fertility Services
139 E. 23rd St., 2nd Floor
New York, NY 10010-3794
 
Dear Dr. Zeitoun & Mr. Acosta:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your firm, located at 139 E. 23rd St., 2nd Floor, New York, NY 10010-3794, from March 14, 2012 through March 22, 2012. During the inspection, the FDA Investigator found 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, Part 1271 (21 CFR 1271), and issued under the authority of Section 361 of the Public Health Service Act (42 USC 264).
 
The deviations documented on the FDA-483, Inspectional Observations, were presented to Mr. Carlo Acosta, Tissue Bank Director, at the conclusion of the inspection and were discussed with Mr. Acosta and Dr. Khaled Zeitoun, Medical Director, who joined the meeting via telephone. The items of concern include, but are not limited to, the following:
               
1.   Failure to screen an anonymous or directed 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 and communicable disease risks associated with xenotransplantation [21 CFR 1271.75(a)(1) and (2)]. For example, records for the following anonymous oocyte donors did not include documentation that the donors were screened for risk factors for, and clinical evidence of, human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease and communicable disease risks associated with xenotransplantation.
 
a.    On August 13, 2011, 19 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 
b.   On August 22, 2011, 26 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from an anonymous donor. 
 
c.    On September 30, 2011, 25 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 
d.   On December 8, 2011, 23 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from an anonymous donor. 
 
e.    On December 15, 2011, 20 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 
f.    On February 8, 2012, 15 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 
g.   On March 15, 2012, 21 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 
2.   Failure to screen an anonymous or directed 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)]. For example, the following donors provided a history of undergoing tattooing, ear piercing, or body piercing in the preceding 12 months; however there was no documentation that the donors were further questioned to determine if sterile procedures were used.
 
a. On a “Health and Family History” form dated February 8, 2012, anonymous oocyte donor (b)(6) documented that she received a tattoo and/or body piercing in July 2011. There is no documentation that the donor was further questioned to determine if sterile procedures were used. On February 8, 2012, 15 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 
b. On a “Health and Family History” form (undated), anonymous oocyte donor (b)(6) documented that she had undergone a tattoo and/or body piercing procedure. There is no documentation of the date of the procedure or documentation that the donor was further questioned to determine if sterile procedures were used. On August 13, 2011, 19 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 
c. On a “Health and Family History” form dated September 23, 2011, anonymous oocyte donor (b)(6) documented that she had undergone both tattoo and body piercing procedures (navel ring, earrings, and two small tattoos). There is no documentation of the dates of the procedures or documentation that the donor was further questioned to determine if sterile procedures were used. On September 30, 2011, 25 oocytes were recovered from anonymous donor (b)(6) and were fertilized with semen from the recipient’s partner. 
 

3. Failure of a responsible person to determine and document the eligibility of an anonymous or directed donor of reproductive cells or tissue [21 CFR 1271.50(a)]. For example, the records for anonymous oocyte donors (b)(6), and (b)(6) were missing documentation to substantiate that a responsible person had determined the donors to be eligible prior to donation. Oocytes were recovered from these donors and were fertilized with semen from the recipient’s partner or an anonymous semen donor. 

 
4. Donor eligibility records are not accurate, indelible, and legible [21 CFR 1271.55(d)(2)]. For example:
 
a. The donor records for anonymous oocyte donors (b)(6), and (b)(6) were missing documentation that a physical examination was performed and/or the date of the examination.
 
b. The test results for Chlamydia trachomatis and Neisseria gonorrhea for anonymous oocyte donor (b)(6) were reported by your testing lab on December 9, 2011. However, the “Initial Donor Screening Checklist” documents that the results were reviewed and accepted by the Medical Director on December 7, 2011.
 
5. Failure to establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part 1271. “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:
 
a. Your standard operating procedure “H.1 Modalities for the Rejection of Anonymous Donors" (revision date 6/1/11) does not include xenotransplantation as a communicable disease risk factor and a criterion for rejection of anonymous donors.
 
b. Your standard operating procedures (SOPs) do not describe the process of accepting donors that are recruited through donor agencies and frequently start their donation cycles at their places of residence. Seven anonymous oocyte donors, (b)(6) and (b)(6), who were recruited from various donor agencies, did not have a personal interview/medical history elaboration (donor medical history interview), as described in your SOPs.
 
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.
 
You should take prompt action to correct these deviations and prevent their recurrence. Failure to do so may result in FDA initiating regulatory action 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 these violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed.
 
Please send your written response to the Food and Drug Administration; Attention:
 
LCDR Frank Verni
Compliance Officer
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
 
If you have any questions about the content of this letter please contact: LCDR Verni at (718) 662-5702.
 
Sincerely,
/S/
Ronald M. Pace
District Director
New York District