# FDA 483 - M FATEH & K SULTAN M D S P C - September 05, 2012

Source: https://www.globalkeysolutions.net/records/483/m-fateh-k-sultan-m-d-s-p-c/51d8c899-912e-436e-a699-4743d012363a

> FDA 483 for M FATEH & K SULTAN M D S P C on September 05, 2012. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: M FATEH & K SULTAN M D S P C
- Inspection Date: 2012-09-05
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The New York Fertility Institute was cited for multiple deficiencies related to the testing, screening, and eligibility determination of anonymous oocyte donors. Observations included failure to perform required communicable disease testing, inadequate screening for risk factors, and deeming ineligible donors as eligible. Additionally, the firm lacked established procedures for donor eligibility, maintained inaccurate records, and failed to provide required documentation to the FDA.

## Related Documents

- [EIR - 2012-09-05](https://www.globalkeysolutions.net/records/eir/m-fateh-k-sultan-m-d-s-p-c/7c452e98-84b5-4e39-baf9-5922183380c7)
- [EIR - 2019-04-25](https://www.globalkeysolutions.net/records/eir/m-fateh-k-sultan-m-d-s-p-c/d25d9bb6-4de1-4d50-a7fb-3171e3c59a5d)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/m-fateh-k-sultan-m-d-s-p-c/569190c7-4412-47e4-9167-9369a95881bd

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