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WARNING LETTER

Celularity, Inc MARCS-CMS 681480 —

Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Signature Required
Product:
Biologics
Recipient:
Recipient Name
Robert J. Hariri, M.D., Ph.D
Recipient Title
Founder, Chairman & CEO
Celularity, Inc

170 Park Avenue
Florham Park, NJ 07932
United States

robert.hariri@celularity.com
Issuing Office:
Office of Compliance and Biologics Quality

United States

WARNING LETTER


December 1, 2025 
 

CBER 25-681480

                
Dear Dr. Hariri:

This is to advise you that the United States Food and Drug Administration (FDA) has reviewed information related to a product that you manufacture, Interfyl®, which is a decellularized human placental connective tissue matrix product derived from the chorionic plate for allogeneic use. FDA has reviewed your website (celularity.com) and your distributor’s website and marketing materials (available at www.arthrex.com, https://www.arthrex.com/orthobiologics/interfyl-connective-tissue-matrix and http://cdn.arthrex.io/image/upload/525a2674-c770-484a-945b-f6037d73b4ac.pdf).  In addition, FDA inspected your facility, located at the above address, between August 14, 2023 and August 22, 2023.  During the inspection, FDA documented that your company manufactures Interfyl®.

This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).  Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1).  A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j).  Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act.  Your introduction or delivery for introduction of your product into interstate commerce, or the causing thereof, is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

Unapproved New Drug and Unlicensed Biological Product Violations

Based on information and records reviewed by FDA, including your website, https://celularity.com (last visited November 2025), and the website and promotional materials of your distributor Arthrex, Inc. (www.arthrex.com),1  your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body.  For example, your product is intended for use in the treatment of certain conditions involving the musculoskeletal system and promoting a healing response, treatment of inflammation and wound healing as well as use in treatment of soft tissue voids, and soft tissue augmentation during repair of surgical defects. Specifically, videos on the Arthrex website promote uses of Interfyl® in treatment of peroneal tendinopathy and tears, achilles tendon tears, non-insertional achilles tendinosis, first metatarsophalangeal joint hallux, stenosing peroneal tenosynovitis, and insertional calcific tendinosis.  In addition, the patient’s guide readily made available to healthcare professionals titled “Interfyl® Human Connective Tissue Matrix – A Patient’s Guide,” available at https://www.arthrex.com/resources/pLB1-000333-en-US/interfyl-human-connective-tissue-matrix-a-patients-guide?referringteam=orthobiologics, indicates that the Interfyl® product works through its chemically active composition, which “contains proteins and biochemicals that support healing.” The guide further indicates that Interfyl® works by “replacing and supplementing the damaged tissue,” describes soft tissue injuries in this context as injuries that “occur to the muscles, tendons, and ligaments,” and includes images depicting various joints in the body. In addition, promotional material and videos on the Arthrex website further promote uses of Interfyl® for wound healing and treatment of inflammation. Therefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).

Your Interfyl® product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR § 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264.  HCT/Ps that do not meet all the criteria in 21 CFR § 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR § 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review.  Based on a review of relevant materials, your company does not qualify for any exception in 21 CFR § 1271.15, and your product fails to meet all criteria in 21 CFR §1271.10(a).

Specifically, your Interfyl® product fails to meet the criterion that the HCT/Ps be “intended for homologous use only,” which means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor.” 21 CFR §§ 1271.3(c) & 1271.10(a)(2).  Your product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor, and the intended uses are not limited to the uses described in the 2004 Request For Designation Letter to Celgene Cellular Therapeutics for the decellularized particulate human placental connective tissue matrix product (replacement or supplementation of damaged or inadequate integumental tissue) that FDA determined qualified for regulation solely under section 361 of the PHS Act.  Rather, your product is also intended for use in the treatment of certain orthopedic conditions, such as healing and repair of soft tissue injuries involving the musculoskeletal system, which involves serving as a connection between muscle and bone and is not a basic function of the chorionic plate in the donor and involves a different organ system from the integumentary system that has distinct functions and components. In addition, stimulation of wound healing and treatment of inflammation are not homologous uses.

Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.2   In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and as a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).

Subject to certain exceptions not applicable here, to lawfully market a new drug that is a biological product, a valid biologics license application (BLA) must be in effect under section 351(a) of the PHS Act, 42 U.S.C. § 262(a).  Such licenses are issued only after showing that the product is safe, pure, and potent.  While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by section 505(i) of the FD&C Act, 21 U.S.C. § 355(i), section 351(a)(3) of the PHS Act, 42 U.S.C. § 262(a)(3), and 21 CFR part 312.  Your product is not the subject of an approved BLA, nor is there an IND in effect.

Responses to the Form FDA-483

We acknowledge receipt of your responses, dated September 12, 2023, October 31, 2023, and December 22, 2023, to FDA’s Form FDA-483.  We have reviewed your responses and concluded that they are not adequate.  For example, your responses contain no corrective actions to the concerns detailed in the FDA-483.  You assert that your products are HCT/Ps that should be regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.  As stated above, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i) that are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and 21 CFR part 1271.

Conclusion

This letter is not intended to be an all-inclusive list of deficiencies.  It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, PHS Act, and their implementing regulations.

Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion.  If you do not believe your product is in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.

Send your electronic response and any questions regarding this letter to CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/s/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality 
Center for Biologics Evaluation and Research

  1. 1Per your Supply and Distribution Agreement with Arthrex, all of Arthrex’s marketing and promotional materials for your placental-derived products are subject to Celularity’s review and approval prior to use. Furthermore, your annual report, FORM 10-K, for the fiscal year ending on December 31, 2023, states that you entered into a six-year supply and distribution agreement with Arthrex, Inc. on May 7, 2021, which includes an exclusive license for the distribution and commercialization of Interfyl® within the United States in the field of orthopedic surgery.
  2. 2Because your product fails to meet at least one criterion in 21 CFR § 1271.10(a), this letter does not evaluate all other criteria in 21 CFR § 1271.10(a).
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