# FDA 483 - The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. - January 14, 2015

Source: https://www.globalkeysolutions.net/records/483/the-center-for-human-reproduction-dba-american-infertility-of-new-york-pc/3775e86f-3680-4158-be4f-3fcaeaebcfad

> FDA 483 for The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. on January 14, 2015. 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: 2015-01-14
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of American Infertility of NY in New York, NY, conducted from January 6-14, 2015, identified a significant procedural deficiency. The firm lacked adequate written procedures to ensure compliance with donor eligibility requirements and to prevent the transmission of communicable diseases. This included a failure to define how staff should record and justify departures from established procedures.

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## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)

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