On December 1, 2025, Celularity Inc., (the "Company") received a warning letter (the "Letter") from the U.S. Food and Drug Administration (the "FDA"). The Letter relates to the use of certain marketing material for Interfyl, a human connective tissue matrix. The Letter states that in order for the product to be marketed consistent with the issued Request for Designation (Section 361 of CFR 1271.10) the Company must limit the use of outcome-based claims and metabolic activity within the body.
The Letter does not restrict the Company's ability to manufacture or ship products, require recall of any products, nor restrict the Company's ability to seek FDA 510(k) clearance of products. In 2004, the FDA issued to the Company the Request for Designation for Interfyl.
The Company takes the matters identified in the Letter very seriously and is committed to working with the FDA to resolve them and continue its comprehensive efforts to remediate the observations. The Company is not aware of any additional actions stemming from the Letter that will have a material impact on its previously announced operational or financial expectations. The Company cannot give any assurances that the FDA will be satisfied with the Company's response or as to the expected date of the resolution of the matters included in the Letter. Until the issues cited in the Letter are resolved to the FDA's satisfaction, additional regulatory action may be taken without further notice.
On December 1, 2025, Celularity Inc., (the "Company") received a warning letter (the "Letter") from the U.S. Food and Drug Administration (the "FDA"). The Letter relates to the use of certain marketing material for Interfyl, a human connective tissue matrix. The Letter states that in order for the product to be marketed consistent with the issued Request for Designation (Section 361 of CFR 1271.10) the Company must limit the use of outcome-based claims and metabolic activity within the body.
The Letter does not restrict the Company's ability to manufacture or ship products, require recall of any products, nor restrict the Company's ability to seek FDA 510(k) clearance of products. In 2004, the FDA issued to the Company the Request for Designation for Interfyl.
The Company takes the matters identified in the Letter very seriously and is committed to working with the FDA to resolve them and continue its comprehensive efforts to remediate the observations. The Company is not aware of any additional actions stemming from the Letter that will have a material impact on its previously announced operational or financial expectations. The Company cannot give any assurances that the FDA will be satisfied with the Company's response or as to the expected date of the resolution of the matters included in the Letter. Until the issues cited in the Letter are resolved to the FDA's satisfaction, additional regulatory action may be taken without further notice.
<p>On December 1, 2025, Celularity Inc., (the "Company") received a warning letter (the "Letter") from the U.S. Food and Drug Administration (the "FDA"). The Letter relates to the use of certain marketing material for Interfyl, a human connective tissue matrix. The Letter states that in order for the product to be marketed consistent with the issued Request for Designation (Section 361 of CFR 1271.10) the Company must limit the use of outcome-based claims and metabolic activity within the body.</p><p> </p><p>The Letter does not restrict the Company's ability to manufacture or ship products, require recall of any products, nor restrict the Company's ability to seek FDA 510(k) clearance of products. In 2004, the FDA issued to the Company the Request for Designation for Interfyl.</p><p> </p><p>The Company takes the matters identified in the Letter very seriously and is committed to working with the FDA to resolve them and continue its comprehensive efforts to remediate the observations. The Company is not aware of any additional actions stemming from the Letter that will have a material impact on its previously announced operational or financial expectations. The Company cannot give any assurances that the FDA will be satisfied with the Company's response or as to the expected date of the resolution of the matters included in the Letter. Until the issues cited in the Letter are resolved to the FDA's satisfaction, additional regulatory action may be taken without further notice.</p>