Inspections, Compliance, Enforcement, and Criminal Investigations
Reproductive Medicine Institute IVF, LLC 3/19/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Ste. 200
RETURN RECEIPT REQUESTED
March 19, 2012
Fernando L. Gomez, MD
Reproductive Medicine Institute IVF, LLC
258 S Chickasaw Trail, Ste 310
Orlando, FL 32825-3501
Dear Dr. Gomez:
The Food and Drug Administration (FDA) conducted an inspection of your firm, Reproductive Medicine Institute IVF, LLC located at 258 S Chickasaw Trail, Ste 310, Orlando, FL from January 23, 2012 through January 25, 2012. 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 USC 264).
The deviations documented on the Form FDA-483, Inspectional Observations were presented to and discussed with you, your Embryology Laboratory Director, Mr. David D. Heinkel, and your office administrator, (b)(6)(b)(7)(c) 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 and tissue, whether viable or nonviable, for evidence of infection due to relevant communicable disease agents and failure to test a specimen from the donor of viable, leukocyte-rich cells or tissue to adequately and appropriately reduce the risk of transmission of relevant cell-associated communicable diseases [21 CFR 1271.85(a) and (b)(1)].
Specifically, communicable disease testing, for all anonymous and directed donors seen by your firm since June 29, 2010, failed to include human immunodeficiency virus, type 1 (HIV-1) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, the antibody to hepatitis B core antigen (anti-HBc), and where appropriate, human T-lymphotropic virus, types I and II (HTLV-I/II). For example:
a. Testing for directed oocyte donor #(b)(6)(b)(7)(c), performed on July 20, 2011, did not include HIV-1/HCV NAT and anti-HBc. Nine oocytes were recovered from donor #(b)(6)(b)(7)(c) on January 7, 2011 and were used for in-vitro fertilization procedures. Six embryos were implanted to the recipient on January 12, 2011.
b. Testing for directed semen donor #(b)(6)(b)(7)(c), performed on December 20, 2011 did not include HIV-1/HCV NAT, anti-HBc, and HTLV-I/II. Semen was collected from donor #(b)(6)(b)(7)(c) on December 15, 2011.
2. 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 30 days before recovery for oocyte donors or up to seven days after recovery [21 CFR 1271.80(b)]. For example, the testing specimen from directed oocyte donor #(b)(6)(b)(7)(c) was collected on July 20, 2010; however nine oocytes were recovered from donor #(b)(6)(b)(7)(c) on January 7, 2011 and were used for in-vitro fertilization procedures. Six embryos were implanted to the recipient on January 12, 2011.
3. 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]. For example, records for directed semen donor #(b)(6)(b)(7)(c) and directed oocyte donor #(b)(6)(b)(7)(c) did not include documentation of a donor medical history interview, as defined in 21 CFR 1271.3(n).
4. Failure of a responsible person to determine and document the eligibility of a donor of reproductive cells or tissue [21 CFR 1271.50(a)]. The records for directed oocyte donor #(b)(6)(b)(7)(c) and directed semen donor #(b)(6)(b)(7)(c) did not contain documentation of a donor eligibility determination, including the name of the responsible person who made the determination and the date of the determination.
5. Failure to ensure that establishments who, by contract, agreement, or other arrangement, perform any manufacturing steps for you are 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, there is no documentation of which test kits are used by (b)(4) and (b)(4), for donor testing for relevant communicable diseases, and that the test kits are FDA-licensed, approved, or cleared donor screening tests.
6. 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 Standard Operating Procedure (SOP), Section IV: Donor Eligibility (subpart C, page 20) does not include HIV-1/HCV NAT as a required donor screening test to adequately and appropriately reduce the risk of transmission of relevant communicable diseases.
In addition, we note that in your SOP Section IV: Donor Eligibility (subpart C), the required testing for directed and anonymous donors includes a separate test for the antibody to Hepatitis B core antigen (anti-HBc) IgG and a separate test for anti-HBc IgM. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, testing for Hepatitis B virus includes a test for the total antibody to the Hepatitis B core antigen
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 FDA’s regulatory requirements,
We acknowledge receipt of your letter dated February 8, 2012 that provides a response to FDA’s inspectional observations. We have reviewed the corrective actions summarized in your response and we have determined that the response is inadequate to address our concerns.
Your response did not provide any details describing the corrective actions you have implemented or plan to implement. You did not indicate which SOPs will be revised and what the revisions will include. We are particularly concerned with the deficiencies outlined on the Form FDA 483 and in this letter in regard to donor testing, screening and eligibility determination. These corrective actions should include communicable disease testing and donor eligibility of future donors and 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. Please explain what corrective action you will take in regard to completing eligibility determinations and communicable disease testing for these donors.
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.
We request that you notify this office in writing, within 15 working days of the 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.
Emma R. Singleton
Director, Florida District