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U.S. Department of Health and Human Services

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Enforcement Actions

Jarrett Fertility Group, LLC 09-Oct-08

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

Public Health Service
Food and Drug Administration

 

Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

WARNINGLETTER
2009-DT-O1

October 9, 2008

John C. Jarrett, M.D.
Owner
Jarrett Fertility Group, LLC
11725 North Illinois Street
Suite 520
Carmel, Indiana 46032

Dear Dr. Jarrett:

The Food and Drug Administration (FDA) conducted inspections of your three related Carmel, Indiana human reproductive tissue establishments (Jarrett Fertility Group, 11725 N. Illinois Street, Suite 520; Heartland Andrology and Laboratory Services LLC, 11725 N. Illinois Street, Suite 520 and Heartland Reproductive Biology LLC, 11700 North Meridian Street) from March 7 through April 11, 2008. During the inspections, the FDA investigator documented 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).

At the conclusion of the inspections, the deviations documented on three separate Forms FDA 483 were presented to, and discussed with, you. The items of concern included:

1. Failure to test a specimen from an anonymous or directed reproductive donor of cells or tissue for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. Specifically:

a. On January 18, 2006, 21 oocytes were recovered from directed donor KJFG. 1001 and were fertilized with semen from the recipient's partner. On January 21, 2006, three resulting embryos were transferred to recipient KG. Donor KJFG 1001 was not tested for human immunodeficiency virus, type 2.

b. On February 3, 2008, three oocytes were recovered from donor CJFG 1031 and were fertilized with semen from sexually-intimate partner CJFG 1032. On February 6, 2008, two resulting embryos were transferred to directed gestational carrier SG. Donors CJFG 1031 and CJFG 1032 were not tested for human immunodeficiency virus, type 1 and hepatitis C virus by the nucleic acid test method.

2. 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 Human T-lymphotropic virus, types I and 11(HTLV-I/TI) and/or cytomegalovirus (CMV) [21 CFR 1271.85(b)]. Specifically:

a. On June 21, 2006 and January 8, 2007, semen was collected from donor CJFG 1009 and was used to fertilize oocytes from the donor's sexually-intimate partner,(CJFG 1007). On June 24, 2006 and January 11, 2007, two resulting embryos were transferred to directed gestational carrier BF. Semen donor CJFG 1009 was not tested for HTLV-I/11 and CMV.

b. On October 18, 2007, semen was collected from donor CJFG 1028 and was used to fertilize oocytes from the donor's sexually-intimate partner (CJFG1029). On October 21 2007, two resulting embryos were transferred to directed gestational carrier JP. Semen donor CJFG 1028 was not tested for CMV.

c. On February 3, 2008, semen was collected from donor CJFG 1032 and was used to fertilize oocytes from the donor's sexually-intimate partner (CJFG1031). On February 6, 2008, two resulting embryos were transferred to directed gestational carrier SG. Semen donor CJFG 1032 was not tested for HTLV-I/II and CMV.

3. 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 [21 CFR 1271.85(c)]. Specifically, your establishment failed to test for Chlamydia trachomatis and/or Neisseria gonorrhea in the following instances where the HCT/Ps were not recovered by a method that ensures freedom from contamination of the cells or tissue by infectious disease organisms that maybe present in the genitourinary tract:

a. On October 10, 2005, three oocytes were recovered from directed donor KJFG 1000 and were fertilized with semen from the recipient's partner. On October 13, 2005, two resulting embryos were transferred to recipient LA. The donor was not tested for Chlamydia trachomatis and Neisseria gonorrhea.

b. On March 4, 2008, 16 oocytes were recovered from directed donor KJFG 1034 and were fertilized with semen from the recipient's partner. On March 7, 2008, two resulting embryos were transferred to recipient KR. The donor was not tested for Neisseria gonorrhea.

c. On November 30, 2006, 19 oocytes were recovered from directed donor KJFG 1018 and were fertilized with semen from an anonymous semen donor. On December 3, 2006, two resulting embryos were transferred to recipient AB. The donor was not tested for Neisseria gonorrhea.

d. On June 21, 2006 and January 8, 2007, semen was collected from donor CJFG 1009 and was used to fertilize oocytes, recovered on the same days, from the donor's sexually-intimate partner(CJFG 1007). On June 24, 2006 and January 11, 2007, two resulting embryos were transferred to directed gestational carrier BF. Semen donor CJFG 1009 was not tested for Chlamydia trachomatis and Neisseria gonorrhea and oocyte donor CJFG 1007 was not tested in connection with the January 8, 2007 donation.

e. On October 18, 2007, semen was collected from donor CJFG 1028 and was used to fertilize oocytes, recovered on the same day, from the donor's embryos were transferred to directed gestational carrier JP. The semen donor and oocyte donor were not tested for Neisseria gonorrhea.

f. On February 3, 2008, semen was collected from donor CJFG 1032 and was used to fertilize oocytes, recovered on the same day, from the donor's sexually-intimate partner (CJFG 1031). On February 6, 2008, two resulting embryos were transferred to directed gestational carrier SG. The semen donor and oocyte donor were not tested for Neisseria gonorrhea.

4. Failure to collect a donor specimen for testing for relevant communicable diseases within 30 days prior to oocyte recovery or up to seven days after oocyte recovery or up to seven days before or after recovery for semen donors [21 CFR 1271.80(b)]. Records indicate that donor specimens were not collected within the required timeframe for the following donors:

a. The specimen from directed donor KJFG 1000 was collected on August 29, 2005; however oocyte recovery was performed on October 10, 2005.

b. The specimen from directed donor KJFG 1013 was collected on July 12, 2006; however oocyte recovery was performed on January 31, 2007,

c. Specimens from directed donor KJFG 1021 were collected on January 12, 2007 and February 1, 2007; however oocyte recovery was performed on March 16, 2007.

d. The specimen from directed donor KJFG 1025 was collected on April 17,2007; however oocyte recovery was performed on July 25, 2007.

e. The specimen from directed donor KJFG 1034 was collected on January 10, 2008; however oocyte recovery was performed on March4, 2008.

f. The specimen from directed donor KJFG 1018 was collected on October 27,.2006; however oocyte recovery was performed on November 30, 2006.

g. The specimens from sexually-intimate partners CJFG 1007 (oocyte donor) and CJFG 1009 (semen donor) were collected on June 5, 2006 and June 2, 2006, respectively. Oocyte recovery and semen donation were performed on January 8, 2007 with subsequent embryo transfer to directed gestational carrier BF.

h. The specimens from sexually-intimate partners CJFG 1029 (oocyte donor) and CJFG 1028 (semen donor) were collected on September 17, 2007 and September 7, 2007; respectively. Oocyte recovery and semen donation were performed on October 18, 2007 with subsequent embryo transfer to directed gestational carrier SG.

i. The specimens from sexually-intimate partners CJFG 1031 (oocyte donor) and CJFG 1032 (semen donor) were collected on December 20, 2007 and December 31, 2007, respectively. Oocyte recovery and semen donation were performed on February 3, 2008 with subsequent embryo transfer to directed gestational carrier SG.

5. Failure to screen an anonymous or directed reproductive 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 1271.75(a)]. Specifically, records for directed semen donor TF did not include documentation of a donor medical history interview, as defined in 21 CFR 1271.3(n), and physical examination of a living donor (both required as relevant medical records under 21 CFR 1271.3(s)). As a result, there was no documentation related to risk factors for the relevant communicable disease agents listed in 21 CFR 1271.3(r). On June 30, 2006 and May 29, 2007, semen was collected from directed donor TF and was used for artificial insemination of recipient DG during three fertilization cycles.

6. Failure to retain documentation associated with testing for relevant communicable disease agents, donor screening for communicable diseases, and donor eligibility determination for donors of reproductive cells or tissue [21 CFR 1271.55(d)(1)and (3)]. Specifically, records for the following donors did not include: (1) the complete results and interpretation of testing for relevant communicable disease agents; (2) the results and interpretation of all donor screening for communicable diseases; and (3) the name of the responsible person who made the donor eligibility determination and the date of the determination.

a. On March 12, 2006, three embryos, created from oocytes from recipient LW and semen from a donation from directed donor DW on August 26, 2005, were transferred to recipient LW. The donor eligibility determination for semen donor DW was made by [redacted] and the semen sample was shipped to your facility for oocyte fertilization.

b. On September 19, 2005, four oocytes were recovered from recipient KN and were fertilized with semen from directed semen donor MN. On September 22, 2005, two resulting embryos were transferred to recipient KN and one embryo was cryopreserved. On June 29, 2007, the cryopreserved embryo was transferred to recipient KN. The semen was shipped to your facility from another facility for oocyte fertilization.

The above-identified deviations 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 FDA regulations. You are responsible for reviewing your operations as a whole to assure you are in compliance with all applicable FDA regulatory requirements.

We acknowledge receipt of your letters dated April 22, 2008 and April 28, 2008 that provide responses to FDA's inspectional observations for all three locations. We have reviewed the corrective actions outlined in the response and have found them inadequate to address our concern. We request that you provide documentation to show that your procedures were updated to reflect that all screening and testing for future directed donations will be completed as required.

We understand that you contacted recipients in regard to re-testing their directed donors when required communicable disease testing was not performed. While you stated that all recipients indicated they did not want their donors to be contacted for re-testing, we remind you that your firm is obligated to screen and test anonymous and directed donors according to the regulations under 21 CFR Part 1271. Therefore, please explain in detail, in your response letter, what corrective action you will take in regard to completing communicable disease testing and eligibility determinations for these donors. We also request that you detail any additional corrective actions you have taken and provide complete documentation to demonstrate that the corrective actions are being appropriately implemented.

We also note that a "Departure From Procedure Documentation Form" was included in the records for your directed donors with incomplete donor testing and/or screening. The form was used to document that the recipients acknowledged that donor screening and/or testing were not completed as required, but agreed to proceed with the procedure since the donors were known to them. Under 21 CFR 1271.47(d), "You must record and justify any departure from a procedure relevant to preventing risks of communicable disease transmission at the time of its occurrence. You must not make available for distribution any HCT/P from a donor whose eligibility is determined under such a departure unless a responsible person has determined that the departure does not increase the risks of communicable disease transmission through the use of the HHCT/P." In the Guidance for Industry: Eligibility Determination for Donors of Human Cells Tissues and Cellular and Tissue-Based Products HCT/Ps (August 27, 2007) [http://www.fda.gov/cber/gdlns/tissdonor.htm], FDA clarifies that a departure from procedures is an "intended change from an established procedure,including a standard operating procedure (SOP), which occurs before the HCT/Pis distributed, and is consistent with applicable regulations and standards." We note that the departures from procedures for your directed donors were not consistent with applicable regulations, which require donor testing in accordance with 21 CFR 1271.80 and 1271.85, and donor screening in accordance with 21 CFR 1271.75 for anonymous and directed reproductive donors of cells or tissue.

You should take prompt action to correct these deviations and prevent their recurrence. Failure to do so may result in regulatory action without further notice. For example, FDA may issue an order to cease manufacturing of HCT/P's.

We request that you notify this office, in writing, within fifteen (15) working days of receipt of this letter, with further details of the specific steps you have taken to correct the noted deviations, including an explanation of each step being taken to prevent the recurrence of similar deviations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.

Your reply should be sent to the Sandra Williams, Compliance Officer, Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions, please feel free to contact Ms. Williams at (313) 393-8118.

Sincerely your,

/S/

Joanna M. Givens
District Director
Detroit District Office