# FDA 483 - The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. - May 01, 2024

Source: https://www.globalkeysolutions.net/records/483/the-center-for-human-reproduction-dba-american-infertility-of-new-york-pc/f6dd223e-1b53-444c-94be-09c7b18dbcea

> FDA 483 for The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. on May 01, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Center For Human Reproduction d.b.a. American Infertility of New York, P.C.
- Inspection Date: 2024-05-01
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. in New York, NY, revealed significant deficiencies in donor screening, eligibility determination, record-keeping, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to adequately screen oocyte donors for communicable disease risks, maintain accurate donor records, establish procedures for directed semen donors, and properly label HCT/Ps from ineligible donors. These issues indicate a moderate level of severity regarding patient safety and regulatory compliance in reproductive human tissue handling.

## Related Documents

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- [483 - 2017-03-03](https://www.globalkeysolutions.net/records/483/the-center-for-human-reproduction-dba-american-infertility-of-new-york-pc/23840d5f-7f28-4491-a38e-d8aabc18cec9)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/the-center-for-human-reproduction-dba-american-infertility-of-new-york-pc/07b7749f-c2f4-4163-bed2-b42b2babfe11

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