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

Source: https://www.globalkeysolutions.net/records/warning_letter/center-for-reproductive-health-joliet-ivf-llc/63f2939f-fe70-4a25-92fe-aa0f09ab6cf8

> FDA WARNING_LETTER for Center for Reproductive Health Joliet IVF LLC on February 03, 2017. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Center for Reproductive Health Joliet IVF LLC
- Inspection Date: 2017-02-03
- Product Type: Biologics
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.globalkeysolutions.net/companies/center-for-reproductive-health-joliet-ivf-llc/0f1087b8-cd5d-4f0b-9257-ce19d7ecaebd

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669