WARNING LETTER
Louisville Reproductive Center MARCS-CMS 533267 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameDr. Robert J. Homm, MD
- Louisville Reproductive Center
4123 Dutchman Lane, Suite 416
Louisville, KY 40207-4733
United States
- Issuing Office:
- Los Angeles District Office
United States
Los Angeles District | |
WARNING LETTER
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
August 29, 2017
Warning Letter #OBPO 17-03
Warning Letter #OBPO 17-03
Dr. Robert J. Homm, MD
Medical Director
Louisville Reproduction Center
4123 Dutchman Lane, Suite 416
Louisville, KY 40207-4733
Dear Dr. Homm,
The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Louisville Reproduction Center, located at 4123 Dutchman Lane, Suite 416, Louisville, KY 40207, from June 7 through June 15, 2017. During the inspection, an 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, List of Inspectional Observations, were presented to and discussed with you at the conclusion of the inspection. These items of concern include, but are not limited to, the following:
1. Failure to screen a 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:
A. The forms “Fertility and Endocrine Associates Personal Health Inventory” and “Oocyte Donor Screening Questionnaire” are relevant medical records used to determine donor eligibility. Your facility determined oocyte donors eligible that were missing one or both forms.
Directed Oocyte donor (b)(6) oocytes were retrieved on (b)(4), 2016.
Directed Oocyte donor (b)(6) oocytes were retrieved on (b)(4), 2016.
Directed Oocyte donor (b)(6) oocytes were retrieved on (b)(4), 2016
Directed Oocyte donor (b)(6) oocytes were retrieved on (b)(4), 2017.
Directed Oocyte donor (b)(6) oocytes were retrieved on (b)(4), 2017.
B. Two semen donors failed to complete a donor screening questionnaire and the “Fertility and Endocrine Associates Personal Health Inventory” form. A donor eligibility determination was not documented for the following semen donors:
- Semen donor (b)(6) semen was collected on (b)(4), 2016.
- Semen donor (b)(6) semen was collected on (b)(4), 2016.
C. In the Guidance for Industry: Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (March 2016), FDA provided establishments that make donor eligibility determinations of HCT/Ps with recommendations for screening donors for evidence of and risk factors for infection with the Zika virus. The “Fertility and Endocrine Associates Personal Health Inventory” and “Oocyte Donor Screening Questionnaire” forms used to screen Donor 069-15 did not screen for the Zika Virus. The oocytes were retrieved on September 30, 2016.
D. Your “Oocyte Donor Screening Questionnaire” does not include questions related to the following conditions and behaviors that increase the donor’s relevant communicable disease risk.
- Persons who have tested positive or reactive for West Nile Virus (WNV) infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.
- Persons who have had a medical diagnosis or suspicion of WNV infection. These donors should be deferred for 120 days following diagnosis or onset of illness, whichever is later. (See section IV.E of the HCT/P Donor Eligibility Determination Guidance).
- Question 26a on your Oocyte Donor Screening Questionnaire states, “Since 1980 have you received a transfusion of blood, platelets, plasma, cryoprecipitate, or granulocytes in the UK?” However, the question should include France and read, “….transfusion of blood or blood components in the U.K. or France between 1980 and the present.” (See section IV.E of the HCT/P Donor Eligibility Determination Guidance).
As a result, your donors have not been screened in accordance with 21 CFR 1271.75.
2. Failure to perform a complete donor screening procedure within the previous six months [21 CFR 1271.75 (e)]. Specifically:
A. The “Oocyte Donor Screening Questionnaire” for anonymous donor (b)(6) was completed on April (b)(4), 2015. Oocytes were retrieved on December (b)(4), 2015 without obtaining an update questionnaire.
B. The “Oocyte Donor Screening Questionnaire” for anonymous donor (b)(6) was completed on January (b)(4), 2015. Oocytes were retrieved on September (b)(4), 2016 without obtaining an update questionnaire.
We have reviewed your response dated June 19, 2017. We acknowledge the corrective actions outlined to your donor testing and screening procedures, including implementation of revised forms. However, your response addresses changes to your “Oocyte Donor Screening Questionnaire” form and does not address donor screening and relevant communicable disease testing for semen donors. 21 CFR 1271.3(s) defines the term “relevant medical records” to include a current report of the physical examination of a living donor. Both the “Fertility and Endocrine Associates Personal Health Inventory” form and “Oocyte Donor Screening Questionnaire” form fail to include a physical assessment of all donors for evidence of high risk behavior and clinical signs and symptoms of relevant communicable disease.
Regarding cryopreserved embryos in storage at your facility, 21 CFR 1271.90(b) states that an embryo originally intended for reproductive use for a specific individual or couple that is subsequently intended for directed or anonymous donation is excepted from the prohibition on use even when the applicable donor eligibility requirements under Subpart C of this part are not met. Should you chose to utilize cryopreserved embryos you currently have in storage in the future, you must comply with the labeling requirements at 21 CFR 1271.90(c).
The deviations identified above 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 the federal regulations. You are responsible for reviewing your firm’s operations as a whole to assure that you are in compliance with all of the FDA regulatory requirements.
You should take prompt action to correct the violations addressed in this letter and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations and prevent their recurrence. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed.
Your response should be sent to the following address: Daniel W. Cline, 19701 Fairchild, Irvine, CA 92612 or emailed to Daniel.Cline@fda.hhs.gov. If you should have any questions, please contact Daniel Cline, Compliance Officer at 949-608-4433 or via e-mail.
Sincerely,
/S/
Karlton Watson
Acting Program Division Director
Office of Biological Products Operations – Division 2