Celularity Inc – FDA 483, Aug 22, 2023

Celularity Inc. in Florham Park, NJ, was inspected and cited for multiple significant deficiencies in its manufacturing processes for human placental connective tissue matrix products (Interfyl) and decellularized, dehydrated human placenta tissue matrix products (CentaFlex). The inspection revealed failures in process validation, final product testing, component control, expiration date determination, stability testing for reconstitution, in-process material testing, and labeling control. These issues indicate a lack of adequate controls to assure drug product identity, strength, purity, and quality.