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U.S. Department of Health and Human Services

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Enforcement Actions

Florida Fertility Institute 12/12/13

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX:            407-475-4770 

 

VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-01
December 12, 2013
 
Mark D. Sanchez, M.D.
IVF Director
Florida Fertility Institute, P.A.
2454 N. McMullen Booth Road, Suite 601
Clearwater, FL 33759
 
Dear Dr. Sanchez:
 
The Food and Drug Administration (FDA) conducted an inspection of your firm, Florida Fertility Institute located at 2454 N. McMullen Booth Road, Suite 601, Clearwater, Florida, from August 30 through September 6, 2013. During this inspection, the 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, 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 Form FDA 483, 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 test a specimen from an anonymous or directed reproductive donor of cells and tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. For example:
 
a.    The donor specimen collected from directed oocyte donor (b)(6) on April 11, 2013 was not tested for total antibody to Hepatitis B core antigen (anti-HBc) (IgG and IgM), human immunodeficiency virus, type 1 (HIV-1) by the nucleic acid test (NAT) method, and hepatitis C virus (HCV) NAT.
 
b.    There is no record that directed oocyte donor (b)(6) was tested for HIV-1/2, hepatitis B virus, hepatitis C virus, and Treponema pallidum at the time of oocyte recovery on April 10, 2012
 
c.    There is no record that directed semen donor (b)(6) was tested for HIV-1/2, hepatitis B virus, hepatitis C virus, and Treponema pallidum at the time of semen recovery on April 27, 2010.
 
2.    Failure to test a specimen from an anonymous or directed reproductive donor of cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract. The reproductive cells or tissue were not recovered by a method that ensured freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract [21 CFR 1271.85(c)]. For example, there is no record that anonymous oocyte donor (b)(6), directed oocyte donor (b)(6), directed oocyte donor (b)(6), and directed semen donor (b)(6) were tested for Chlamydia trachomatis and Neisseria gonorrhea at the time of oocyte or semen recovery.
  
3.    Failure to test a specimen from an anonymous or directed reproductive donor of viable, leukocyte-rich cells or tissue to adequately and appropriately reduce the risk of transmission of relevant cell-associated communicable diseases including cytomegalovirus (CMV) and Human T-lymphotropic virus, types I and II (HTLV-I/II) [21 CFR 1271.85(b)]. For example, semen was collected from directed donor (b)(6) on April 27, 2010. Donor (b)(6) was not tested for CMV and HTLV-I/II at the time of semen collection.
 
4.    Failure to determine as ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent in accordance with 1271.85 [21 CFR 1271.80(d)(1)]. For example, the specimen from anonymous oocyte donor (b)(6), collected on April 13, 2010, tested positive for Chlamydia trachomatis. Donor (b)(6) was determined eligible on April 27, 2010 and fifteen oocytes were recovered from the donor the same day.
 
5.    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 up to 30 days before recovery for oocyte donors or up to seven days after recovery [21 CFR 1271.80(b)]. For example;
 
a.    The testing specimen for directed oocyte donor (b)(6) was collected on May 23, 2011; however fifteen oocytes were recovered from donor (b)(6) on July 18, 2011 and were used for in-vitro fertilization procedures.
 
b.    The testing specimen for directed oocyte donor (b)(6) was collected on April 11, 2013; however eleven oocytes were recovered from donor (b)(6) on May 29, 2013.
 
6.    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)]. Under 21 CFR 1271.75(a), you must screen a donor of 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 1271.3(s) defines 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, your records for the following donors lack documentation of your review of a current donor medical history interview and/or a current report of the physical examination of the donor. For each of these donations, the most recent medical history interview and/or physical examination of the donor had occurred more than six months before the date of recovery of the cells or tissue.[1]
 
a.    Semen was collected from directed donor (b)(6) on March 27, 2012 and April 15, 2013. The last documented physical examination was performed on September 13, 2006, and the last medical history interview was documented on September 20, 2006. The semen was used for in-vitro fertilization procedures.
 
b.    Semen was collected from a directed donor (b)(6) on April 27, 2010. The last documented physical examination was performed on August 4, 2008, and the last medical history interview was documented on August 11, 2008. The semen was used for in-vitro fertilization procedures.
 
c.    Oocytes were recovered from anonymous donor (b)(6) on June 17, 2011. The last documented physical examination was performed on August 31, 2010, and the last medical history interview was documented on September 14, 2010. The oocytes were used for in-vitro fertilization procedures.
 
d.    Oocytes were collected from anonymous donor (b)(6) on September 10, 2011 and November 2, 2011. The last medical history interview was documented on February 28, 2011. The oocytes were used for in-vitro fertilization procedures.
 
e.    Oocytes were collected from an anonymous donor (b)(6) on February 11, 2013. The last documented physical examination was performed on July 26, 2012. The oocytes were used for in-vitro fertilization procedures.
 
f.    Your firm’s “Donor Screening” questionnaire does not include questions related to the following conditions and behaviors that increase the donor’s relevant communicable disease risk:
 
i.    Persons who have been exposed in the preceding 12 months to known or suspected HIV, HBV and/or HCV-infected blood through percutaneous inoculation (e.g. needle stick) or through contact with an open wound, non-intact skin, or mucous membrane.
 
ii.      Persons who have had sexual contact in the preceding 12 months with any person with hemophilia or other related clotting disorders who has received human-derived clotting factor concentrates in the preceding 5 years.
 
iii.      Persons who acquired a clinically recognizable vaccinia virus infection by contact with someone who received a smallpox vaccine.
 
7.    Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with 1271.75 and donor testing in accordance with 1271.80 and 1271.85. A responsible person must determine and document the eligibility of a donor of reproductive cells or tissue [21 CFR 1271.50(a)]. For example:
 
a.    There was no documentation of a donor eligibility determination for the following donors:
                                                             
i.      Oocytes were recovered from directed donor (b)(6) on May 29, 2013.
 
ii.      Oocytes were recovered from directed donor (b)(6) on July 18, 2011 and were used for in-vitro fertilization procedures.
 
iii.      Semen was collected from directed donor (b)(6) on April 27, 2010 and was used for in-vitro fertilization procedures. 
 
b.    Oocytes were recovered from anonymous (b)(6) on July 31, 2012 and were used for in-vitro fertilization procedures on August 3, 2012. (b)(6) was not determined eligible until August 20, 2012.
 
c.    Oocytes were recovered from anonymous donor (b)(6) on March 27, 2012.   Donor (b)(6) was determined eligible on March 28, 2012 prior to receipt of the results of testing for Chlamydia trachomatis and Neisseria gonorrhea, which were reported by your testing laboratory on March 30, 2012.
 
d.    Oocytes were recovered from anonymous donor (b)(6) on February 11, 2013 and were used for in-vitro fertilization procedures. Donor (b)(6) was determined eligible on February 4, 2013 prior to documentation of the medical history interview on February 9, 2013. 
 
e.    Semen was collected fromdirected donor (b)(6) April 15, 2013 and was used for in-vitro fertilization procedures. Donor (b)(6) was determined eligible on April 1, 2013 prior to collection of a donor specimen for testing for relevant communicable diseases on April 15, 2013.
 
8.    Failure to ensure that an establishment that performs any step in manufacture for you, by contract, agreement or other arrangement, complies with applicable CGTP requirements [21 CFR 1271.150(c)(1)(iii)].   For example, there is no evidence that your firm ensured that the contract testing laboratory, which performs testing for relevant communicable diseases for your donors, is in compliance with current good tissue practice requirements and is using appropriate FDA-licensed, approved, or cleared donor screening tests.
 
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 written responses dated September 25, 2013, and September 30, 2013. We have reviewed the corrective actions summarized in your responses and we have determined that the responses are inadequate to address our concerns. The responses outline changes to your donor testing and screening procedures, including implementation of revised forms for donor screening and donor eligibility determinations. However, your responses address only prospective changes to your practices and do not address the inadequacy of donor screening and relevant communicable disease testing for all previous anonymous and directed HCT/P donors for whom screening and/or testing was not performed. You also did not address the increased risk of communicable disease transmission for any HCT/Ps from these donors that are remaining in storage at your firm. Use of these HCT/Ps is not in compliance with 21 CFR 1271.
 
In addition, your response to Observation 2 of the FDA 483 states, “Please see attached documentation included that shows anonymous oocyte donor (b)(6) did have Chlamydia and Gonorrhea testing prior to retrieval on 9/15/2009 which were not originally included in the patient’s chart.” We did not find any documentation of additional testing results for donor (b)(6) included with your response.
 
You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations noted above, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include in your response documentation of the corrective actions you have taken. If you cannot complete all corrections before you respond, state the reason for the delay and the timeframe within which the corrections will be completed.
 
Please send your reply to the Food and Drug Administration, Attention: Andrea H. Norwood, Compliance officer at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norwood at (407) 475-4724.
 
Sincerely,
/S/
Emma R. Singleton
Director, Florida District


[1] Under 21 CFR 1271.75(e), an abbreviated donor screening procedure may be used on repeat donations from a living donor if the establishment has performed a complete donor screening procedure, including a current donor medical history interview and a physical examination, within the previous six months.