Vivex Biologics, Inc.August 4, 2022

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

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Record Details

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.

Company: Vivex Biologics, Inc.
Inspection Date: August 4, 2022
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
People: Sergio E. Delgado
Christopher J. Adams
Lura Baquero

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ID · af689f42-0c7e-4eee-bd15-92dad40cf41a