R. Scott Springer
- Center for Reproductive Health Joliet IVF LLC
2246 Weber Rd.
Crest Hill, IL 60403
- Issuing Office:
- Chicago District Office
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Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187
July 6, 2017
UPS NEXT DAY
Center for Reproductive Health/ Joliet IVF LLC
Dr. R. Scott Springer, DO, Medical Director
2246 Weber Rd.
Crest Hill, IL 60403
CMS #: 519531
Dear Dr. Springer:
The Food and Drug Administration (FDA) conducted an inspection of your firm, Center for Reproductive Health/ Joliet IVF LLC, located at 2246 Weber Rd. Crest Hill, Illinois, from January 18, 2017, through February 3, 2017. During the inspection, the FDA investigator documented deviations from the regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (CFR) Part 1271 (21 CFR 1271), and issued under the authority of Section 361 of the Public Health Service Act (42 U.S.C. § 264).
The deviations documented on the Form FDA 483, Inspectional Observations, were presented to, and discussed with you at the conclusion of the inspection. Additional deviations were noted upon further review of the donor records and procedures collected during the inspection. These deviations are discussed below. The items of concern include, but are not limited to, the following:
1. Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with 1271.75 and donor testing in accordance with 1271.80 and 1271.85 [(21 CFR 1271.50(a)]. The eligibility of oocyte donors was determined and documented prior to receipt of the results of donor testing for relevant communicable disease agents. For example:
a. A specimen for communicable testing was collected from anonymous oocyte donor (b)(4) on December 29, 2014. The donor was determined to be eligible the same day of specimen collection, but the results were not reported until January 3, 2015.
b. A specimen for communicable testing was collected from anonymous oocyte donor (b)(4) on March 11, 2015. The donor eligibility determination was documented the same day of the specimen collection, but the results were not reported until March 16, 2015.
c. A specimen for communicable testing was collected from directed oocyte donor (b)(4) on January 27, 2016. The donor was determined to be eligible the same day of specimen collection, but the results were not reported until January 29, 2016.
d. A specimen for communicable testing was collected from anonymous oocyte donor (b)(4) on January 27,2016. The donor was determined to be eligible the same day of specimen collection, but the results were not reported until January 29, 2016.
2. Failure of a responsible person to determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50(a)]. For example, the Donor Eligibility Determination Form for anonymous oocyte donors (b)(4) and (b)(4) did not contain any documentation that the donors were determined "eligible" by a responsible person.
3. Failure to retain records that are accurate, indelible, and legible [21 CFR 1271.55(d)(2)]. The records for the following oocyte donors contained multiple dates and/or altered dates on the Donor Physical Assessment Form and/or Medical History Interview Form. For example:
a. The Donor Physical Assessment Form and Medical History Interview Form for anonymous donor (b)(4) are documented with two dates: October 16, 2015 and January 27, 2016. Your Establishment was unable to identify which date accurately reflected when the donor screening and physical examination were performed.
b. The Donor Physical Assessment Form and Medical History Interview Form for anonymous donor (b)(4) have been altered with white-out and are documented with two dates: February 2, 2015 and March 11, 2015. Your establishment was unable to identify which date accurately reflected when the donor screening and physical examination were performed.
c. The Donor Physical Assessment Form and Medical History Interview Form for anonymous donor (b)(4) are documented with two dates: October 20, 2014 and December 29, 2014. Your Establishment was unable to identify which date accurately reflected when the donor screening and physical examination were performed.
d. The Donor Physical Assessment Form and Medical History Interview Form for anonymous donor (b)(4) have been altered with white-out and are documented with two dates: December 18, 2015 and January 27,2016. Your establishment was unable to identify which date accurately reflects when the donor screening and physical examination were performed.
4. 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)]. For example:
a. Your Donor Medical History Interview Form does not include questions related to the following conditions and behaviors that increase the donor's relevant communicable disease risk. As a result, your donors have not been screened in accordance with 21 CFR 1271.75.
i. 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.
ii. Persons who have been treated for or had syphilis within the preceding 12 months.
b. Question 8 on your Donor Medical History Interview form asks about close contact within 12 months preceding donation with another person having clinically active viral hepatitis. However, the question should ask whether the donor has lived with (resided in the same dwelling) another person who has hepatitis B or clinically active (symptomatic) hepatitis C infection in the preceding 12 months. (See section IV .E of the HCT/P Donor Eligibility Determination Guidance).
c. Question 13 on your Donor Medical History Interview form regarding a medical diagnosis of WNV infection states, "If the answer is yes to this question defer donation for 28 days from onset of symptoms .... " However, persons who have had a medical diagnosis or suspicion of WNV infection 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).
d. Question 27 on your Donor Medical History Interview form states, "Have you received any transfusion of blood or blood components in the U.K. between 1980 and the present?" However, the question should 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).
5. Failure to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility, and complying with all other requirements of Subpart C "Donor Eligibility" in 21 CFR Part 1271.45-1271.90. "Establish and maintain" means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47(a)]. Our review of your procedure "HCT/Ps Procedure Manual" found that it has not been reviewed or revised since 2010. For example:
a. The procedure does not include HIV-1/HCV/HBV NAT as a required donor screening test for anonymous and directed donors to adequately and appropriately reduce the risk of transmission of relevant communicable diseases.
b. The procedure states, "A positive test to HBsAg may not make the donor ineligible" under the donor testing section for both anonymous and directed donors. As required under 21 CFR 1271.80(d)(1), you must determine a donor to be ineligible whose specimen tests reactive on a screening test for a communicable disease agent, including Hepatitis B virus. Accordingly, you are required to determine a donor who tests reactive for HBsAg as ineligible.
c. The donor testing section for directed donors, the procedure states, "A positive result would require special labeling of HCT/P." This statement applies to a positive testing result for HIV, hepatitis B, hepatitis C, syphilis, HTLV, CMV, Chlamydia, and Gonorrhea. While special labeling is required for HCT/Ps from donors with positive testing result, we also note that under 21 CFR 1271.80(d)(1), you must determine a donor whose specimen tests reactive on a screening test for a communicable disease agent to be ineligible in accordance with 1271.85. This regulation applies to both anonymous and directed donors. Under 21 CFR 1271.65(b), you are not prohibited from using HCT/Ps from an ineligible directed reproductive donor.
Finally, we have the following additional comments regarding your firms operations:
1. Your Donor Medical History Interview form and HCT/P Procedural Manual does not include questions for screening donors for evidence of and risk factors for, infection with Zika virus. (See FDA's 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,
2. We would also like to clarify the requirements for donor screening in accordance with 21 CFR 1271.75. While the regulations under 21 CFR 1271.80(b) require the collection of a donor specimen for testing up to 30 days before recovery or up to seven days after recovery for oocyte donors, this timeframe does not apply to the donor medical history interview and physical examination. While both of these records are considered relevant medical records and are required to be reviewed as part of donor screening, the acceptable timeframe for performance of these donor screening activities is within six months prior to recovery of HCT/Ps.
3. Since you did not respond to the observations noted on the FDA-483, there is no assurance that you have implemented, or intend to implement, corrective actions to prevent recurrence of the deviations observed during the current inspection.
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 federal regulations. You are responsible for reviewing your operations as a whole to assure you are in compliance with FDA's regulatory requirements.
You should take prompt action to correct the violations described in this letter and prevent their recurrence. 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 fifteen (15) working days of receiving this letter, of specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.
Please send your reply to: Samuel Labinjo, Compliance Officer, Food & Drug Administration, Office of Biological Product Operations-Division 2, 550 West Jackson Boulevard, Suite 1500, Chicago, IL 60661. Refer to the Unique Identification Number (CMS# 519531) when replying. If you have any questions about this letter, please contact Mr. Labinjo via email at Samuel.firstname.lastname@example.org
or by phone at 312-596-4254.
Acting Program Division Director
Office of Biological Products Operations-Division 2
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