| Public Health Service Food and Drug Administration |
Los Angeles District
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Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
March 29, 2010
W/L 12-10
John L. Couvaras, M.D.
dba IVF Phoenix
9817 N 95th St., Building I-105
Scottsdale, AZ 85258
Dear Dr. Couvaras:
The Food and Drug Administration (FDA) conducted an inspection of your firm, located at 9817 N 95th St., Building I-105, Phoenix, Arizona, from February 1, 2010 to February 5, 2010. During this 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 a Form 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 determine as ineligible, a donor whose specimen tests reactive on a screening test for a communicable disease agent [21 CFR 1271.80(d)(1)]. For example:
a. Semen donor (b)(6) tested reactive on a screening test for the antibody to hepatitis B core antigen (anti-HBc) on December 19, 2007. You determined the donor to be eligible, despite the reactive test result. Six vials of semen were collected and frozen on December 13, 2007 for future use. On October 4, 2009, one semen vial was thawed and was used to fertilize oocytes from anonymous donor (b)(6). On October 8, 2009, two embryos were transferred to surrogate (b)(6). Additionally, during the inspection, the investigator noted the HCT/Ps from this donor were not labeled in accordance with 21 CFR 1271.65(b)(2). FDA regulations do not preclude the use of HCT/Ps from ineligible donors provided the donor is a directed reproductive donor, the HCT/Ps are 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)).
b. Anonymous oocyte donor (b)(6) tested positive for Chlamydia trachomatis on September 30, 2009. Oocytes were retrieved from donor (b)(6) on October 12, 2009 and fertilized oocytes were used to create embryos which were transferred to the recipient on October 15, 2009.
2. Failure to follow established procedures for determining donor eligibility [21 CFR 1271.47(a)]. For example, the ''Donor Summary of Records" form for anonymous oocyte donor (b)(6) is missing documentation that the donor is eligible or ineligible. Oocytes were retrieved from donor (b)(6) on October 4, 2009 and were transferred as embryos to the recipient on October 8, 2009. In addition, donor (b)(6) answered "don't know" to a question on the donor screening questionnaire, without any documentation that the donor was further questioned regarding the answer. Your procedure SOP # 01, (b)(4) states that "donors who answer "yes" or "don't know" to any of the FDA specific questions will be rejected."
The deviations identified above are not intended to provide 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 you are in compliance with all applicable FDA regulatory requirements.
We acknowledge receipt of your letter dated February 22, 2010 that provides responses to FDA's inspectional observations of your facility. We have reviewed the corrective actions outlined in the response and have found them generally adequate in regard to your updated procedures and labeling for HCT/Ps :from ineligible donors. However, we continue to be concerned about your practice of documenting departures from procedures and deviations from regulatory requirements.
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) (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/P is distributed, and is consistent with applicable regulations and standards."
Your procedure SOP #14 (b)(4) describes the process for documenting the justification to an HCT/P donor who does not meet the donor eligibility requirements under 21 CFR 1271. This procedure was followed when documenting (on form (b)(4) the justification to allow anonymous oocyte donor (b)(6) to donate, despite testing positive for Chlamydia trachomatis. A departure or deviation from procedures must be consistent with the regulations under 21 CFR 1271. A donor eligibility determination, which includes testing in accordance with 21 CFR 1271.80 and 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 (1271.65(b)). 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.
You should take prompt action to correct these deviations and prevent their recurrence. Failure to do so may result in further regulatory action.
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 violations and to prevent their recurrence. 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 written reply should be sent to:
Alonza E. Cruse
US Food & Drug Administration
19701 Fairchild
Irvine, CA 92612-2446
If you have any questions regarding this letter, please contact Dr. Raymond W. Brullo, Compliance Officer at 949-608-2918.
Sincerely,
/S/
Alonza Cruse
District Director
Los Angeles
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