# FDA 483 - Zhang Medical P.C. d/b/a New Hope Fertility Center - September 15, 2014

Source: https://www.globalkeysolutions.net/records/483/zhang-medical-pc-dba-new-hope-fertility-center/9f76ce7f-877e-4af5-85f0-3281ee09c638

> FDA 483 for Zhang Medical P.C. d/b/a New Hope Fertility Center on September 15, 2014. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhang Medical P.C. d/b/a New Hope Fertility Center
- Inspection Date: 2014-09-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New Hope Fertility Center, a reproductive human tissue establishment in New York, NY, revealed significant deficiencies in donor eligibility determination and associated procedures. The firm failed to properly screen and test oocyte donors, including accepting a donor positive for chlamydia and not collecting specimens at appropriate times. Additionally, there were widespread issues with incomplete physical exams, missing documentation for eligibility determinations, and inadequate written procedures for all steps of donor screening and testing.

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## Related Officers

- [Yvonne M. Santiago](https://www.globalkeysolutions.net/people/yvonne-m-santiago/1cad310c-9aaa-4e77-b71d-4de3329d3ce0)

Company: https://www.globalkeysolutions.net/companies/zhang-medical-pc-dba-new-hope-fertility-center/fd978180-354d-4a5f-af0a-52791de86e52

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961