# FDA 483 - Regenerative Biologics Inc. - February 06, 2020

Source: https://www.keypedia.com/records/483/regenerative-biologics-inc/f915223d-6272-452e-91d7-89702485ffeb

> FDA 483 for Regenerative Biologics Inc. on February 06, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regenerative Biologics Inc.
- Inspection Date: 2020-02-06
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Regenerative Biologics Inc., a human tissue recovery firm in Gainesville, FL, revealed a significant deficiency in donor screening practices. The firm failed to adequately document and identify risk factors for communicable diseases, specifically Zika, in three birth tissue donors whose tissues were recovered from an area designated for active Zika transmission. This oversight indicates a failure to ensure donor eligibility and the safety of recovered tissues.

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.keypedia.com/companies/regenerative-biologics-inc/546031f7-fb56-45e9-bc3c-5c19ff0e39b4

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6