FDA WARNING_LETTER - Center for Reproductive Health Joliet IVF LLC - February 03, 2017

The FDA conducted an inspection of Center for Reproductive Health/Joliet IVF LLC from January 18, 2017, to February 3, 2017, documenting deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to determine donor eligibility based on complete testing results:** Oocyte donor eligibility was determined before receiving communicable disease test results (e.g., donors (b)(4), (b)(4), (b)(4), (b)(4)). 2. **Failure of a responsible person to document donor eligibility:** Donor Eligibility Determination Forms for donors (b)(4) and (b)(4) lacked documentation of eligibility by a responsible person. 3. **Failure to retain accurate, indelible, and legible records:** Records for multiple oocyte donors ((b)(4), (b)(4), (b)(4), (b)(4)) contained multiple or altered dates on physical assessment and medical history forms, preventing accurate identification of screening dates. 4. **Failure to adequately screen donors for communicable disease risks:** The Donor Medical History Interview Form lacked questions for West Nile Virus (WNV) NAT, syphilis treatment within 12 months, proper phrasing for hepatitis B/C exposure, correct deferral period for WNV (120 days vs.