# FDA 483 - Columbia University Fertility Center - July 23, 2019

Source: https://www.keypedia.com/records/483/columbia-university-fertility-center/4e591f2b-44be-4395-99c1-0b5573c0df0b

> FDA 483 for Columbia University Fertility Center on July 23, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Columbia University Fertility Center
- Inspection Date: 2019-07-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Columbia University Fertility Center identified a significant lapse in donor screening practices. The facility deemed an oocyte donor eligible despite her having risk factors for Zika virus infection. This resulted in the donation and subsequent use or cryopreservation of oocytes from a potentially at-risk donor.

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## Related Officers

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

Company: https://www.keypedia.com/companies/columbia-university-fertility-center/8defbab7-4935-4788-9494-a7efdbcb3339

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