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

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.