- Florida Institute for Reproductive Sciences and Technologies
- Issuing Office:
- Florida District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Florida District |
555 Winderley Place, Suite 200
Maitland, Florida 32751
w/ DELIVERY CONFIRMATION
April 12, 2016
Minna R. Selub, MD, Medical Director
Florida Institute for Reproductive Sciences
2300 N. Commerce Parkway, Suite 315
Weston, FL 33326
Dear Dr. Selub:
The Food and Drug Administration (FDA) conducted an inspection at your firm, Florida Institute for Reproductive Sciences and Technologies located at 2300 N. Commerce Parkway, Suite 315 Weston, Florida, from January 11 through January 22, 2016. 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 (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 determine eligibility based on donor screening in accordance with 1271.75 and donor testing in accordance with 1271.80 and 1271.85. A responsible person, as defined in 1271.3(t), must determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50(a)]. Specifically:
a. There is no documentationon file that a Donor Eligibility determination was made by the responsible person for directed semen donors (b)(6) and (b)(6).
b. Donors were determined eligible before communicable testing results were received. For example:
- A specimen for communicable disease testing was collected from directed semen donor (b)(6) on June 1, 2015. The donor, (b)(6), was determined to be eligible on June 1, 2015, but the results were not reported until June 4, 2015.
- A specimen for communicable disease testing was collected from oocyte donor (b)(6) on January 23, 2015. The donor, (b)(6), was determined to be eligible on January 23, 2015, but the results were not reported until January 26, 2015.
- A specimen for communicable disease testing was collected from oocyte donor (b)(6) (formerly (b)(6)) on March 17, 2015. The donor was determined to be eligible on March 13, 2015, but the results were not reported until March 19, 2015.
2. 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)(1)]. Your firm's donor history questionnaire does not include questions related to the following conditions and behaviors that increase the donor's relevant communicable disease risk:
a. Testing positive or reactive for West Nile Virus infection within the preceding 120 days.
b. Treatment for or having been diagnosed with syphilis within the preceding 12 months.
c. Receiving any transfusion of blood or blood components in France between 1980 and the present.
3. Failure to test a specimen from a directed reproductive donor of cells and tissue for evidence of infection due to relevant communicable disease agents in order to adequately and appropriately reduce the risk of transmission of relevant communicable diseases [21 CFR 1271.85(a) and (b)(1)]. For example:
a. Directed semen donor (b)(6) was not tested for Hepatitis C virus (HCV) - NAT (HCV-NAT).
b. Directed semen donor (b)(6) was not tested for Human T-lymphotropic virus (HTLV) types I and II.
4. Failure to collect donor specimens for testing for relevant communicable diseases at the time of recovery of the cells or tissue from the donor; or up to (b)(4) days before or after recovery [21 CFR 1271.80(b)]. Specifically, specimens for communicable disease testing for directed semen donors (b)(6) and (b)(6) were not collected up to (b)(4) days before or after recovery.
We have the following additional concerns regarding your firms operations:
1. Please note that your Donor Medical History Interview form lacks certain questions as indicated in item 2 above. Because of this, none of your donors were appropriately screened for risk factors for and clinical evidence of relevant communicable disease agents and diseases under 21 CPR 1271.75. A donor eligibility determination cannot be completed without this information regarding the donor's medical history. Under 21 CPR 1271.45 (c), an HCT/P must not be implanted, transplanted, infused, or transferred until the donor eligibility has been determined, except as provided under Sections 21 CPR 1271.60(d), 1271.65(b), and 1271.90. You must not release from quarantine any HCT/P from a directed or anonymous donor until you elicit the missing information to complete the donor eligibility determinations.
2. We note that several of these issues were observed during an inspection conducted September 2014, and remain uncorrected as evidence by the current inspection.
3. We note you have failed to respond with corrective actions you intend to take to prevent recurrence of the deviations observed during the current inspection, so we are unable to determine what, if any, corrective actions you have taken.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations noted above, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include in your response documentation of the corrective actions you have taken. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Randall L. Morris, Compliance officer at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Mr. Morris at (407) 475-4741.
Susan M. Turcovski
Director, Florida District