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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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IVF Michigan P.C. 21-Sep-06

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 RECIPT REQUESTED

WARNING LETTER
2006-DT-28

September 21, 2006

Michael H. Fakih, M.D.
President
IVF Michigan P.C.
3950 South Rochester Road
Suite 2300
Rochester Hills, Mi 48307-5165

Dear Dr. Fakih:

The-Food and Drug Administration (FDA) conducted an inspection of the IVF Michigan Rochester Hills location between June 20 and July 10, 2006. During this inspection, the FDA investigator documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/P's) 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 the Form FDA-483 were presented to, and discussed with, Dr. Michael H. Fakih, President, 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, whether viable or nonviable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)], in that testing for the antibody to human immunodeficiency virus, types 1 and/or 2 (anti-HIV-1/2) and/or the antibody. to hepatitis C virus (anti-HCV) was not completed for donor [redacted] although the donor was determined to be eligible. [redacted] were recovered from donor [redacted] on August 24, 2005 and were transferred to two recipients on August 27, 2005.

2. Failure to test specimens from an anonymous or directed reproductive donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the [redacted] [21 CFR 1271.85(c)]. Specifically [redacted]were recovered from donor [redacted] on June 21 2005 without test results for Chlamydia trachomatis and Neisseria gonorrhea. [redacted] of these [redacted] were fertilized with semen from a [redacted] on June 22, 2005 and were frozen as [redacted] without documentation of [redacted] donor eligibility in the recipient's record. On June 24, 2005, three embryos were transferred to another recipient, despite documentation in the recipient's record that the physician was aware that [redacted] donor eligibility had not yet been determined.

3. Failure to determine whether anonymous or directed reproductive donors are eligible based upon the results of donor testing in accordance with 21 CFR 127.80, and 1271.85. 21 CFR 1271.50(a)]. Specifically, donors [redacted] and [redacted] were determined to be eligible, despite the absence of communicable disease testing results for anti-HIV-1/2 and/or anti-HCV and, for donor [redacted] testing results for Chlamydia trachomatis and Neisseria gonorrhea. [redacted] recovery was performed for all eight donors.

4. 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 21 CFR Part 1271, Subpart C - Donor Eligibility. 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, you did not follow your written procedures for completion of the "Screening - Gamete Provider" form, "Clinical Evidence of Disease - Gamete Provider" form, and/or "Summary of FDA Required Communicable Disease Screening/Testing" form, which were missing required signatures, eligibility determinations, and/or dates for donors [redacted] and [redacted]

Please see the enclosed List of Inspectional Observations, which was issued to Michael H. Fakih, M.D., President, at the conclusion of the inspection for additional details.

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 FDA regulations. You are responsible for investigating, determining causes of, and correcting the violations identified by FDA and for reviewing your operations as a whole to assure yourself that you are in compliance with all of the FDA regulatory requirements applicable to human reproductive HCT/P's and your firm.

We acknowledge receipt of your letter dated August 17, 2006 that provided a preliminary response to FDA's inspectional observations . We have reviewed the corrective actions outlined in the response and we have determined that the response is inadequate to address our concerns. The response outlines changes to your donor testing procedures, including implementation of a revised checklist for communicable disease testing requests. These corrective actions appear to address communicable disease testing and donor eligibility of future donors. You did not indicate how you plan to address the failure to determine the eligibility of previously accepted donors for whom communicable disease testing and donor eligibility determinations were not completed prior to oocyte retrieval. Please explain what corrective action you will take in regard to completing eligibility determinations and communicable disease testing for these donors. In your response to this letter, 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.

You should take prompt action to correct these deviations and to prevent their recurrence. Failure to do so may result in further regulatory action. For example, FDA may take possession of and/or destroy violative HCT/P's, or may issue, an order to retain, recall, destroy, or cease manufacture of HCT/P's.

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 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 yours,

/S/

Joan M. Givens
District Director
Detroit District