Kimera Labs, Inc.

Warning LetterOpen

Chief Executive Officer Kimera Labs, Inc. Duncan B. Ross, Ph.D. 2810 N. Commerce Parkway Miramar , FL 33025 United States duncan.ross@kimeralabs.comFEI 3011069063Issued Sep 1, 2023Division of Biological Products Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011069063.

Violations13

Issue DateSep 1, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Kimera Labs, Inc.
Location: Chief Executive Officer Kimera Labs, Inc. Duncan B. Ross, Ph.D. 2810 N. Commerce Parkway Miramar , FL 33025 United States duncan.ross@kimeralabs.com
FEI Number: 3011069063
Country: United States
Issue Date: September 01, 2023
Issuing Office: Division of Biological Products Operations I
Product Type: Medical Devices
Status: Open

Summary

Kimera Labs manufactured and distributed exosome products (XoGlo® and XoGlo®Pro) and an amniotic fluid product (Amnio2X®) that the FDA determined were biologics requiring either an approved biologics license application (BLA) or an active investigational new drug (IND) application. The company lacked required approvals to market these products, with only XoGlo®Pro having an IND in effect as of May 2023, while the other products had no authorization for commercial distribution. The FDA's July 2022 inspection documented that Kimera was distributing these purportedly sterile biological products to practitioners and medical facilities nationwide without proper regulatory approval, constituting violations of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

Kimera Labs, Inc. FDA Warning Letter, September 1, 2023