# FDA 483 - Manhattan Fertility Services LLC - April 06, 2023

Source: https://www.globalkeysolutions.net/records/483/manhattan-fertility-services-llc/fb96e8e6-f20a-44a8-8a3c-e086b5692cc5

> FDA 483 for Manhattan Fertility Services LLC on April 06, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Manhattan Fertility Services LLC
- Inspection Date: 2023-04-06
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Manhattan Fertility Services LLC, a human reproductive tissue establishment in New York, was cited for two observations during an FDA inspection. The firm failed to adequately screen semen donors for communicable disease risk factors, specifically Zika Virus. Additionally, HCT/Ps from ineligible donors, who tested positive for Hepatitis B, were not properly labeled with warning statements.

## Related Documents

- [483 - 2024-11-05](https://www.globalkeysolutions.net/records/483/manhattan-fertility-services-llc/2afc305c-89b9-4d19-93e1-8dba4189735c)

## Related Officers

- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

Company: https://www.globalkeysolutions.net/companies/manhattan-fertility-services-llc/ed1c1165-d7fe-42fe-8f99-d755b4474938

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