| Public Health Service Food and Drug Administration |
555 Winderley Pl., Ste 200 Maitland, Fl 32751 |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
January 26, 2010
FLA-10-11
Diran Chamoun, M.D.
Owner and Medical Director
Fertility and Reproductive Medicine Center for Women
d/b/a: Viera Fertility Clinic
3160 Alzante Circle
Melbourne, FL 32940
Dear Dr. Chamoun:
The Food and Drug Administration (FDA) conducted an inspection of your firm, Fertility and Reproductive Medicine Center for Women, d/b/a: Viera Fertility Clinic located at 3160 Alzante Circle Melbourne, FL from November 4 through November 12, 2009. 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 UDSC 264).
The deviations documented on the Form FDA-483 were presented to, and discussed with, you and your Clinical Director, Ms. Pamela Miles, at the conclusion of the inspection. The items of concern include, but are not limited to, the following.
1. 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 [21 CFR 1271.50(a)]. For example, prior to June 24, 2009 your firm failed to adequately and appropriately test for Anti-hepatits B core antigen and human immunodeficiency virus, type 1 and hepatitis C virus by the nucleic acid test (NAT) method resulting in incomplete donor eligibility determinations for the following oocyte donors:
a) Anonymous oocyte donor (b)(6) was determined to be 'Eligible" on September 19, 2007, February 7, 2008 and June 21, 2008.
b) Anonymous oocyte donor (b)(6) was determined to be "Eligible" on February 7, 2008.
c) Anonymous oocyte donor (b)(6) was determined to be "Eligible" on February 10, 2009.
d) Anonymous oocyte donor (b)(6) was determined to be "Eligible" on February 10, 2009.
e) Anonymous oocyte donor (b)(6) was determined to be "Eligible" on December 7, 2008.
f) Anonymous oocyte donor (b)(6) was determined to be "Eligible" on February 10, 2009.
g) Directed oocyte donor# (b)(6) was determined to be "Ineligible" on December 7, 2008.
2. 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)(1)]. For example, records for directed donors ((b)(6)) and anonymous donors (#(b)(6)) did not include documentation of a donor medical history (social behavior) interview, as defined in 21 CFR 1271.3(n).
3. Failure to ensure that establishments who by contract, agreement or other arrangement, perform any manufacturing steps for you were in compliance with applicable CGTP requirements prior to the initiation of the contract, agreement or other arrangement [21 CFR 1271.150(c)(1)(iii)]. For example, you failed to ensure that the test kits used by (b)(6), for your firm's donor eligibility screening, were FDA licensed, approved or cleared, and/or that your firm has knowledge of what test kits are used by (b)(6), and (b)(6) Laboratory, for testing HTC/Ps.
4. Failure to establish and maintain procedures for all steps that you perform in testing, screening, and determining donor eligibility [21 CFR 1271.47(a)]. For example, your firm's standard operating procedure "Egg Donor Eligibility Determination-SOP 2 is not complete in that, the current "Donor Medical History Interview Form" fails to include a question inquiring if potential donors have been treated for or had syphilis within the preceding 12 months.
In addition, we note that a departure from procedure was recorded for directed donor (b)(6) who was found to be "ineligible" based on incomplete donor testing and/or screening. The Donor Eligibility Form was used to document the two recipients acknowledgement that the donor screening and/or testing were not completed as required, but agreed to proceed with the procedure. 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." We note that the departure from procedures for directed donor (b)(6) is not consistent with applicable regulations, which requires 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 and tissue.
Finally, we have reviewed your standard operating procedure (SOP) "Procedure for Deviations from Established FDA Screening Criteria" SOP-14 which was collected during the current inspection. While deficiencies in this SOP were not included on the Form FDA-483, we note this SOP appears to allow the use of HCT/Ps recovered from an anonymous donor who has been determined to be "ineligible." There is no provision in 21 CFR Part 1271 that allows for the use of oocytes from an anonymous donor who has been determined "ineligible" in accordance with 21 CFR 1271.50.
The above identified violations 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 federal regulations. You are responsible for reviewing your operations as a whole to assure you are in compliance with all of the FDA regulatory requirements,
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. Such action may include, but is not limited to, an order to retain, recall, destroy or cease manufacture of HCT/Ps.
We request that you notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted deviations 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 response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751 If you have any questions about the content of this letter please contact Mr. Alejo at (407) 475-4731.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
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