# FDA WARNING_LETTER - Manhattan Reproductive Medicine, PC - July 31, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/manhattan-reproductive-medicine-pc/b9f4a354-4b0a-4bdc-bdc3-f50e1c44ab0e

> FDA WARNING_LETTER for Manhattan Reproductive Medicine, PC on July 31, 2013. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Manhattan Reproductive Medicine, PC
- Inspection Date: 2013-07-31
- Product Type: Biologics
- Office Name: New York District Office
- Summary: The FDA conducted an inspection of Manhattan Reproductive Medicine, PC, from July 26-31, 2013, identifying significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include:
1.  **Failure to determine donor ineligibility:** An anonymous oocyte donor tested positive for Chlamydia trachomatis twice but was deemed eligible, and oocytes were recovered. (21 CFR 1271.80(d)(1))
2.  **Failure to test for relevant communicable disease agents:** An anonymous oocyte donor was not tested for total antibody to Hepatitis B core antigen (anti-HBc) but was deemed eligible. (21 CFR 1271.85(a))
3.  **Failure to screen donors by reviewing medical records:** Donor medical history questions regarding communicable disease risk factors were not documented for multiple anonymous oocyte donors who were subsequently allowed to donate. (21 CFR 1271.75(a)(1))
4.  **Failure to use appropriate FDA-licensed tests:** The contract testing laboratory used tests not approved for HCT/P donor screening for Hepatitis C virus, HIV, and anti-HBc for several donors. (21 CFR 1271.80(c))
5.  **

## Related Documents

- [483 - 2020-02-12](https://www.globalkeysolutions.net/records/483/manhattan-reproductive-medicine-pc/8d723eb2-e38b-4caf-bbc7-daa6b04ab3bf)
- [483 - 2022-06-29](https://www.globalkeysolutions.net/records/483/manhattan-reproductive-medicine-pc/db28ec06-ca81-490b-b6c5-214c9d25750d)

## Related Officers

- [Patricia A. Clark](https://www.globalkeysolutions.net/people/patricia-a-clark/27d765b4-6b34-4ed9-ae41-fd36b568cfed)
- [Program Director](https://www.globalkeysolutions.net/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

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

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d