Regenerative Biologics Inc.February 6, 2020

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Regenerative Biologics Inc.

Record Details

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.

Company: Regenerative Biologics Inc.
Inspection Date: February 6, 2020
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Barbara T. Carmichael (Investigator at U.S.FDA)

Open in Dashboard

ID · f915223d-6272-452e-91d7-89702485ffeb