Celularity Inc. has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding its marketing practices for Interfyl, a human connective tissue matrix product. The FDA's letter instructs the company to limit the use of outcome-based claims and assertions about metabolic activity in its promotional materials to comply with regulations under Section 361 of CFR 1271.10. While the letter does not restrict manufacturing or shipping operations, nor require a product recall, Celularity faces potential further regulatory action if the FDA's concerns are not resolved. The company states it is working with the FDA to address the issues and does not expect an immediate material impact on its operations or financial outlook.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celularity Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001493152-25-026383), on December 05, 2025, and is solely responsible for the information contained therein.
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