FDA 483 - Stratus BioSystems, LLC - June 11, 2024

Stratus BioSystems, LLC, an HCT/P manufacturer in Grapevine, TX, was inspected from June 3-11, 2024. The inspection revealed a significant deficiency in process validation procedures for their AmnioAMP-MP amniotic membrane product. Specifically, the firm failed to establish and document the allowable hold times for the membrane during manufacturing, leading to concerns about product quality and expiration dating.