FDA 483 - Skye Biologics Holdings LLC - December 09, 2022

Skye Biologics Holdings LLC in El Segundo, CA, was inspected and received a Form FDA 483 with seven observations related to significant deficiencies in their manufacturing and quality control systems for biological flowable allograft products. Key issues include lack of process validation, inadequate laboratory controls and environmental monitoring, absence of endotoxin testing and stability studies, and poor batch record documentation and component identity verification. These findings indicate a serious lack of adherence to GMP requirements, potentially impacting product quality and sterility.