Robert J. Hariri, M.D., Ph.D
Founder, Chairman & CEO
Celularity, Inc
170 Park Avenue
Florham Park , NJ 07932
United States
robert.hariri@celularity.comFEI 3016661001Issued Dec 1, 2025Office of Compliance and Biologics Quality
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016661001.
Violations1
Issue DateDec 1, 2025
Product TypeBiologics
StatusOpen
Letter Details
Firm
Celularity, Inc
Location
Robert J. Hariri, M.D., Ph.D
Founder, Chairman & CEO
Celularity, Inc
170 Park Avenue
Florham Park , NJ 07932
United States
robert.hariri@celularity.com
FEI Number
3016661001
Country
United States
Issue Date
December 01, 2025
Issuing Office
Office of Compliance and Biologics Quality
Product Type
Biologics
Status
Open
Summary
Celularity, Inc. was cited for manufacturing and distributing Interfyl®, a decellularized human placental connective tissue matrix product, as an unapproved new drug and unlicensed biological product in violation of sections 505(a) of the FD&C Act and 351(a)(1) of the PHS Act. The company failed to obtain either an approved New Drug Application or a Biologics License Application before introducing the product into interstate commerce. The FDA identified these violations during a facility inspection conducted in August 2023 and through review of the company's website and distributor marketing materials.
Celularity, Inc FDA Warning Letter, December 1, 2025
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