Celularity receives FDA warning letter over Interfyl marketing claims

Celularity Inc

FDA warning letter received Dec 1, 2025, regarding marketing material for Interfyl (human connective tissue matrix).
Letter cites outcome-based and metabolic activity claims; company must limit such claims per Section 361 of CFR 1271.10.
No restriction on manufacturing, product shipment, recall, or ability to seek 510(k) clearance.
Company states no material impact on operational/financial expectations; resolution timeline uncertain.
Additional regulatory action may occur if issues not resolved to FDA's satisfaction.

item 8.01

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