John J. Zhang, M.D.
Owner, Medical and Tissue Bank Director
Zhang Medical P.C. dba New Hope Fertility Center
4 Columbus Circle, 4th Floor
New York , NY 10019
United StatesFEI 3008769612Issued Jun 24, 2022Office of Biological Products Operations – Division 1
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 3008769612.
Violations11
Issue DateJun 24, 2022
Product TypeBiologics
StatusOpen
Letter Details
Firm
Zhang Medical P.C. dba New Hope Fertility Center
Location
John J. Zhang, M.D.
Owner, Medical and Tissue Bank Director
Zhang Medical P.C. dba New Hope Fertility Center
4 Columbus Circle, 4th Floor
New York , NY 10019
United States
FEI Number
3008769612
Country
United States
Issue Date
June 24, 2022
Issuing Office
Office of Biological Products Operations – Division 1
Product Type
Biologics
Status
Open
Summary
Zhang Medical P.C. dba New Hope Fertility Center, a fertility clinic in New York, failed to comply with FDA regulations governing human cells, tissues, and cellular products (HCT/Ps) during a November 2021 inspection. The facility's critical violations included failure to determine oocyte donors as ineligible despite documented risk factors for communicable diseases, specifically multiple instances where donors with Zika virus exposure or travel history to high-risk areas were incorrectly cleared for donation. These deviations violated 21 CFR Part 1271, which establishes mandatory donor screening and eligibility determinations required under the Public Health Service Act.
Zhang Medical P.C. dba New Hope Fertility Center FDA Warning Letter, June 24, 2022
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