Jeffrey Fisch, MD
Medical Director
Green Valley Fertility Partners
2950 W. Horizon Ridge
Henderson , NV 89074
United States
milissa@gvflv.comFEI 3010953558Issued Dec 3, 2025Center for Biologics Evaluation and Research (CBER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010953558.
Violations7
Issue DateDec 3, 2025
Product TypeBiologics
StatusOpen
Letter Details
Firm
Green Valley Fertility Partners
Location
Jeffrey Fisch, MD
Medical Director
Green Valley Fertility Partners
2950 W. Horizon Ridge
Henderson , NV 89074
United States
milissa@gvflv.com
FEI Number
3010953558
Country
United States
Issue Date
December 03, 2025
Issuing Office
Center for Biologics Evaluation and Research (CBER)
Product Type
Biologics
Status
Open
Summary
Green Valley Fertility Partners failed to adequately test reproductive donors for communicable diseases as required under federal regulations for human cells and tissues (HCT/Ps), specifically missing West Nile Virus (WNV) nucleic acid testing during the required June-October screening periods. The company marked donors as "eligible" without documented test results for WNV NAT, including at least one donor from whom oocytes were recovered in June 2024. This was a repeat violation—the same testing deficiency had been previously cited during an FDA inspection in April 2022—demonstrating the company's failure to correct known compliance gaps.
Green Valley Fertility Partners FDA Warning Letter, December 3, 2025
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