FDA WARNING_LETTER - Celularity Inc - August 22, 2023

On December 1, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Celularity, Inc. following an inspection of its Florham Park, NJ facility between August 14 and August 22, 2023. The letter details significant violations concerning the company"s product, Interfyl®, a decellularized human placental connective tissue matrix. The FDA determined that Interfyl® is being unlawfully marketed as an unapproved new drug and an unlicensed biological product. This violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and section 351(a)(1) of the Public Health Service Act (PHS Act). The agency found that Celularity"s and its distributor"s marketing materials promote Interfyl® for therapeutic uses, such as treating orthopedic conditions (e.g., tendinopathy, Achilles tendon tears), wound healing, and inflammation. These intended uses extend beyond the product"s basic function and are not limited to homologous use as defined for human cell, tissue, or cellular or tissue-based products (HCT/Ps) under 21 CFR Part 1271. As a result, Interfyl® is regulated as a drug and biological product, requiring an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application, neither of which Celularity possesses. The company is required to cease manufacturing and distributing the product for these unapproved uses until full compliance with all applicable regulatory requirements is achieved.