FDA 483 - Vivex Biologics, Inc. - August 04, 2022

An FDA inspection of Vivex Biologics, Inc. in Miami, FL, a tissue processor, revealed that facilities were not maintained in a good state of repair. Specifically, electrical outlets in ISO-5 cleanroom processing areas showed extensive corrosion, rust buildup, and chipping paint. These conditions were observed in rooms used for processing HCT/P bone products, indicating potential issues with environmental control and product integrity.