# FDA 483 - Empire Medical Practice, PC d.b.a Kindbody - September 03, 2021

Source: https://www.globalkeysolutions.net/records/483/empire-medical-practice-pc-dba-kindbody/6eb466cf-6586-4831-bfd0-36e3dba6b0fb

> FDA 483 for Empire Medical Practice, PC d.b.a Kindbody on September 03, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Empire Medical Practice, PC d.b.a Kindbody
- Inspection Date: 2021-09-03
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Empire Medical Practice, PC d.b.a Kindbody in New York, NY, a reproductive human tissue establishment, revealed one significant observation. The firm failed to ensure HCT/P donors were determined eligible based on complete donor screening and testing results. Specifically, a donor was deemed eligible before all communicable disease test results were available.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/empire-medical-practice-pc-dba-kindbody/fb6e0ed9-a607-4d3b-8441-77b4e0df6ff4

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