# FDA EIR - IVF New York - February 03, 2010

Source: https://www.keypedia.com/records/eir/ivf-new-york/ff25fd7a-b360-4a8f-8911-a59f1200d1d9

> FDA EIR for IVF New York on February 03, 2010. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: IVF New York
- Inspection Date: 2010-02-03
- Product Type: biologics
- Office Name: New York District Office
- Summary: An FDA surveillance inspection of IVF New York, a reproductive tissue facility located at 230 Central Park S, New York, NY, was conducted on February 3, 2010. The inspection assessed the company's operations as a Reproductive Tissue Facility and Directed Donor Egg Program, aligning with regulatory guidelines for Human Cells, and Cellular and Tissue-Based Products (HCT/Ps). The firm is registered with the FDA for processing, storing, and distributing oocytes, semen, and embryos, and is also licensed by the NYSDOH. While a previous inspection in 2008 had noted a verbal observation regarding a past failure to register with the FDA for 2007 and 2008, this issue was no longer a concern. During the current inspection, no deficiencies were identified, and the firm's written procedures were found to be current and compliant. As a result, no FDA Form 483, which lists inspectional observations, was issued. The final regulatory decision for this inspection was "No Action Indicated," meaning no further actions were required from the FDA.

## Related Documents

- [EIR - 2012-09-06](https://www.keypedia.com/records/eir/ivf-new-york/0f62df54-e96f-4b2c-a6a5-26716664bc1d)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/elizabeth-m-jacobson/0850cd14-6541-4c17-925b-ccb4b162537d)
- [Amy Wyan Mai](https://www.keypedia.com/people/amy-wyan-mai/90fddb04-0ff0-4096-9f21-70935ccfb26d)

Company: https://www.keypedia.com/companies/ivf-new-york/8315db0b-29f8-4651-a35c-1dd2b2020ab1

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