Kimera Labs, Inc. MARCS-CMS 649343 — June 12, 2026

CLOSEOUT LETTER

• Delivery Method: Via Email
• Product: Biologics; Drugs

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• Recipient: Duncan B. Ross, Ph.D.; Chief Executive Officer; Kimera Labs, Inc.; 2810 N. Commerce Parkway; Miramar, FL 33025-3958; United States; duncan.ross@kimeralabs.com

• Issuing Office: Division of Biological Products Operations I; United States

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Dear Dr. Ross:

The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions set forth in your correspondences dated September 13, 2023, September 26, 2023, and March 19, 2024, in response to our Warning Letter dated September 01, 2023, and our response review letter dated March 07, 2024, which regarded violations relating to your Amnio2X®, XoGlo® and XoGlo®Pro products. Based on your representation that Kimera Labs has ceased the manufacture, sale, and distribution of these three products and removed them from your website and all sales channels, including through any third-party partners or affiliates, it appears that you have addressed the violations contained in this Warning Letter. FDA conducted a follow-up inspection of your firm at the above address between August 19, 2024, and August 21, 2024, and did not find evidence of continued manufacturing or distribution of the three products listed above.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action. If you have any questions regarding this letter, please contact the Division of Case Management, CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/
Vincent Amatrudo, JD
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research