# FDA 483 - Eversight - February 19, 2019

Source: https://www.globalkeysolutions.net/records/483/eversight/c093cb3e-6f5b-4baa-8f7d-c742778aa876

> FDA 483 for Eversight on February 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eversight
- Inspection Date: 2019-02-19
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Eversight, a human tissue establishment in Clark, NJ, revealed two significant observations related to donor eligibility. The firm failed to ensure that a responsible person properly determined and documented HCT/P donor eligibility based on screening and testing results. Additionally, HCT/Ps were not accompanied by a statement indicating the donor's eligibility status after the determination was completed.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jennifer-l-custodio/489a8b9c-ab8d-4d37-b89c-6086889e825c)

Company: https://www.globalkeysolutions.net/companies/eversight/3e2c7eb6-1612-4466-aafd-abe8c42da52c

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248