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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Balin, Martin S., MD, PhD 10/10/12

  

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

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863 

 

October 10, 2012
 
WARNING LETTER
 
CHI-2-13
 
 
VIA UPS Next Day
 
Martin S. Balin, MD, PhD
2825 N. Halsted St.
Chicago, IL 60657
 
Dear Dr. Balin:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your firm, located at 2825 N. Halsted St., Chicago, Illinois, from June 20, 2012 through August 17, 2012.  During this inspection, an 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 a Form FDA-483, Inspectional 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 to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract [21 CFR 1271.85(c)]. For example, the relevant communicable disease testing results for the following donors did not include testing for Chlamydia trachomatis and Neisseria gonorrhea. Despite the missing test results, the donors were determined eligible.
 
a.       Fifteen oocytes were recovered from anonymous donor (b)(6) on October 30, 2009, and were fertilized with semen from the recipient’s partner. Donor (b)(6) was determined eligible on October 30, 2009.
 
b.      Ten oocytes were recovered from anonymous donor (b)(6) December 11, 2009, and were fertilized with semen from the recipient’s partner. Donor (b)(6) was determined eligible on December 11, 2009.
 
c.       Twenty oocytes were recovered from directed donor (b)(6) on October 28, 2011, and were fertilized with semen from the recipient’s partner. Donor (b)(6) was determined eligible on October 17, 2011.
 
d.      Ten oocytes were recovered from anonymous donor (b)(6) on July 6, 2012, and were fertilized with semen from the recipient’s partner. Donor (b)(6) was determined eligible on July 5, 2012.
 
2.      Failure to test a specimen from an anonymous or directed reproductive donor of cells and tissue, whether viable or nonviable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. Specifically, communicable disease testing for the following oocyte donors failed to include  human immunodeficiency virus, type 1 (HIV-1)  and hepatitis C virus (HCV) by the nucleic acid test (NAT) method. For example:
 
a.      Specimens for communicable disease testing were collected from directed donor (b)(6) on May 7, 2010. Twelve oocytes were recovered from donor (b)(6) on May 21, 2010 and were fertilized with semen from the recipient’s partner. Donor (b)(6) was determined eligible on May 7, 2010.
 
b.      Specimens for communicable disease testing were collected from directed donor (b)(6) on October 12, 2011 and October 21, 2011. Twenty oocytes were recovered from donor (b)(6) on October 28, 2011 and were fertilized with semen from the recipient’s partner. Donor (b)(6) was determined eligible on October 17, 2011.
 
c.       Specimens for communicable disease testing were collected from anonymous donor on (b)(6) July 5, 2012. Ten oocytes were recovered from anonymous donor (b)(6) on July 6, 2012, and were fertilized with semen from the recipient’s partner. Donor (b)(6) was determined eligible on July 5, 2012.
 
3.   Failure to test using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases [21 CFR 1271.80(c)]. For example, there is no documentation of which test kits are used by LifeSource Testing Laboratory and HealthLab, for donor testing for relevant communicable diseases, and that the test kits are FDA-licensed, approved, or cleared donor screening tests.
 
4.   Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with Part 1271.75 and donor testing in accordance with Part 1271.80 and Part 1271.85 [21 CFR 1271.50(a)]. Specifically, the eligibility of the following oocyte donors was determined and documented prior to receipt of the results of donor testing for relevant communicable disease agents. For example: 
 
a.       Specimens for communicable disease testing were collected from directed donor (b)(6) on May 7 and 17, 2010 and the results were reported on May 9 and 18, 2010, respectively. Donor (b)(6) was determined eligible on May 7, 2010, prior to receipt of all results of donor testing for relevant communicable disease agents.
 
b.      Specimens for communicable disease testing were collected from directed donor (b)(6) on October 12 and 21, 2011 and the results were reported on October 13 and 23, 2011, respectively. Donor (b)(6) was determined eligible on October 17, 2011, prior to receipt of all results of donor testing for relevant communicable disease agents.
 
c.       Specimens for communicable disease testing were collected from anonymous donor (b)(6) on July 5, 2012 and the results were reported on July 6, 2012. Donor (b)(6) was determined eligible on July 5, 2012 prior to receipt of all results of donor testing for relevant communicable disease agents.
 
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)].  For example, records for directed oocyte donor (b)(6) did not include documentation of a physical examination and a medical history interview, noted in [21 CFR 1271.3(s)] as part of the donor’s relevant medical records.
 
6.   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, your SOP (b)(4) “Egg Donor Initial Eligibility Determination Based on Communicable Disease Criteria” (b)(4) does not include HIV-1 NAT and HCV NAT as FDA-required donor screening tests.
 
We are also concerned about your SOP (b)(4) “Deviations from Established Egg Donor/Intended Parent FDA Screening Criteria.” We would like to clarify that 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 HCT/P.” In the Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (b)(4) [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/P is distributed, and is consistent with applicable regulations and standards.” 
 
A donor eligibility determination, which includes testing in accordance with 21 CFR 1271.80 and Part  1271.85, and donor screening in accordance with 21 CFR 1271.75, is required for all anonymous and directed reproductive donors of cells or tissue. Use of HCT/Ps from an ineligible donor is not prohibited, in the case of a directed reproductive donor, provided the HCT/P from the donor is properly labeled, and you document that you notified the physician using the HCT/P of the results of testing and screening 21 CFR 1271.65(b)]. A departure from procedures should not be used to justify violations of the regulations in 21 CFR 1271 prior to or after an HCT/P has been transferred. The regulations under 21 CFR 1271 do not allow for recipients to consent to the receipt of HCT/Ps from an ineligible anonymous reproductive donor.
 
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 the deviations addressed in this letter and prevent their recurrence.  Failure to do so may result in FDA initiating regulatory action without further notice. 
 
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your response should be sent to Matthew Sienko, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. If you have any questions about the content of this letter, please contact Mr. Sienko at 312-596-4213.
 
Sincerely,
/S/ 
Scott J. MacIntire
District Director