# FDA 483 - Manhattan Reproductive Medicine, PC - June 29, 2022

Source: https://www.globalkeysolutions.net/records/483/manhattan-reproductive-medicine-pc/db28ec06-ca81-490b-b6c5-214c9d25750d

> FDA 483 for Manhattan Reproductive Medicine, PC on June 29, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Manhattan Reproductive Medicine, PC
- Inspection Date: 2022-06-29
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Manhattan Reproductive Medicine, PC, a human reproductive tissue establishment, was cited for deficiencies during an FDA inspection. The firm failed to adequately screen oocyte donors for communicable disease risk factors, specifically Zika Virus, due to an incomplete questionnaire. Additionally, the firm lacked established written procedures for utilizing its electronic donor screening system.

## Related Documents

- [WARNING_LETTER - 2013-07-31](https://www.globalkeysolutions.net/records/warning_letter/manhattan-reproductive-medicine-pc/b9f4a354-4b0a-4bdc-bdc3-f50e1c44ab0e)
- [483 - 2020-02-12](https://www.globalkeysolutions.net/records/483/manhattan-reproductive-medicine-pc/8d723eb2-e38b-4caf-bbc7-daa6b04ab3bf)

## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)
- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

Company: https://www.globalkeysolutions.net/companies/manhattan-reproductive-medicine-pc/f1e37e01-c834-4079-b040-ce28daed3fa9

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