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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Center for Fertility and Gynecology 09-Oct-08

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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

October 9, 2008

WL 01-09

Michael Vermesh, M.D., Owner
The Center for Fertility and Gynecology
18370 Burbank Blvd., #301
Tarzana, CA 91356

Dear Dr. Vermesh:

The Food and Drug Administration (FDA) conducted an inspection of your firm, located at 18370 Burbank Blvd., #301, Tarzana, California, from June 17 through 24, 2008. 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 test specimens from anonymous or directed reproductive donors 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)]. Specifically, three semen donors [redacted] and [redacted] were tested for one or more relevant communicable disease agents listed in 21 CFR 1271.85(a) and (b), by a laboratory that did not use FDA-licensed, approved, or cleared donor screening tests:

a. On April 3, 2006, semen was collected from directed donor [redacted] and was used to fertilize oocytes from an anonymous oocyte donor. On March 16, 2007, two resulting embryos were transferred to surrogate [redacted] and nine embryos were cryopreserved for future use.

b. On June 12, 2007, semen was collected from directed donor [redacted] and was used to fertilize oocytes from an anonymous oocyte donor. On July 21, 2007, three resulting embryos were transferred to recipient [redacted]

c. On February 29, 2008, semen was collected from directed donor [redacted] who was also the intended parent, and was used to fertilize oocytes from an anonymous oogyte donor. On March 3, 2008, three resulting embryos were transferred to surrogate [redacted] and six embryos were cryopreserved for future use.

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 relevant communicable diseases [21 CFR 1271.85(b)]. Specifically, your establishment failed to test for Human T-lymphotropic virus, types I and II (HTLV-IM) and/or cytomegalovirus (CMV) for the following semen donors:

a. On June 12, 2007, semen was collected from directed donor [redacted] and was used to fertilize oocytes from an anonymous oocyte donor. On July 21, 2007, three resulting embryos were transferred to recipient [redacted]

b. On February 29, 2008, semen was collected from directed donor [redacted] who was also the intended parent, and was used to fertilize oocytes from an anonymous oocyte donor. On March 3, 2008, three resulting embryos were transferred to surrogate [redacted] and six embryos were cryopreserved for future use.

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 a specimen from donors [redacted], [redacted] and [redacted] for Chlamydia trachomatis and 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 may be present in the genitourinary tract:

a. On August 9, 2005, nine oocytes were recovered from anonymous donor [redacted] and were fertilized with semen from the recipient's partner. On August 12, 2005, two resulting embryos were transferred to recipient [redacted] and five embryos were cryopreserved for future use.

b. On June 12, 2007, semen was collected from directed donor [redacted] and was used to fertilize oocytes from an anonymous oocyte donor. On July 21, 2007, three resulting embryos were transferred to recipient [redacted].

c. On February 29, 2008, semen was collected from directed donor [redacted] who was also the intended parent, and was used to fertilize oocytes from,an anonymous oocyte donor. On March 3, 2008, three resulting embryos were transferred to surrogate [redacted] and six embryos were cryopreserved for future use.

4. 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 seven days before or after recovery [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 [redacted] was collected on June 1, 2007; however semen donation occurred on June 12, 2007.
b. The specimen from directed donor [redacted] was collected on November 29, 2007; however semen donation occurred on February 29, 2008.

5. Failure to screen an anonymous or directed 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)]. Specifically, records for semen donors [redacted], [redacted] and [redacted] and for oocyte donors [redacted], [redacted], and [redacted] did not include documentation of a donor medical history interview, as defined in 21 CFR 1271.3(n), nor did they include 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).

a. Semen was collected from directed donor [redacted] directed donor [redacted], and directed donor [redacted] and was used to fertilize oocytes from anonymous oocyte donors. The resulting embryos were transferred to the recipients or to a surrogate or were cryopreserved for future use.

b. Oocytes were recovered from anonymous donor [redacted], anonymous donor [redacted], and directed donor [redacted] and were fertilized with semen from the recipients' partner or an anonymous semen donor. The resulting embryos were transferred to the recipients or to a surrogate or were cryopreserved for future use.

6. Failure of a responsible person to determine and document the eligibility of an anonymous or directed donor of reproductive cells or tissue [21 CFR 1271.50(a)]. Specifically, no documentation was found during the review of seven donor records to substantiate that a responsible person from your firm had determined the donors to be eligible prior to donation.

a. Semen was collected from directed donor [redacted], directed donor [redacted], and directed donor [redacted] and was used to fertilize oocytes from anonymous oocyte donors. The resulting embryos were transferred to the recipients or to a surrogate or were cryopreserved for future use.

b. Oocytes were recovered from anonymous donors [redacted], [redacted] and [redacted] and directed donor [redacted] and were fertilized with semen from the recipient's partner or an anonymous semen donor. The resulting embryos were transferred to the recipients or to a surrogate or were cryopreserved for future use.

7. Failure to establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for CMV [21 CFR 1271.85(b)(2)]. ("Establish and maintain" means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis (21 CFR 1271.47(a))). Specifically, your SOP 11 titled "Anonymous Gamete Donation SOP," requires that upon receipt of a positive CMV test result for a semen donor, the IVF coordinator (or designee) will inform the physician of record of the result. The physician will then notify the donor and the recipient or surrogate of the positive CMV test result and request that the recipient or surrogate give consent to proceed with the embryo transfer. On April 7, 2006, your firm received a positive CMV test result for semen donor [redacted] There is no documentation that the physician of record, donor, and surrogate were notified of the positive result. In addition, there is no documentation that surrogate [redacted] consented to proceed with the embryo transfer.

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. 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.

If you have any questions regarding this letter, please contact Ms. Mariza Jafary, Compliance Officer at 949-608-2977.

Your written reply should be sent to:

John Larry Stevens,
Acting Director, Compliance Branch
US Food & Drug Administration
19701 Fairchild
Irvine, CA 92612-2446

Sincerely,

/S/

Alonza E. Cruse
District Director
Los Angeles

Cc: Jeff Farrar, DVM, PhD, MPH
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413