Zonghai Li, M.D.
Chief Executive Officer
CARsgen Therapeutics Corporation
4022 Stirrup Creek Drive
Durham , NC 27703
United States
zonghaili@carsgen.comFEI 3020703259Issued Jul 26, 2024Center for Biologics Evaluation and Research
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 3020703259.
Violations6
Issue DateJul 26, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
CARsgen Therapeutics Corporation
Location
Zonghai Li, M.D.
Chief Executive Officer
CARsgen Therapeutics Corporation
4022 Stirrup Creek Drive
Durham , NC 27703
United States
zonghaili@carsgen.com
FEI Number
3020703259
Country
United States
Issue Date
July 26, 2024
Issuing Office
Center for Biologics Evaluation and Research
Product Type
Drugs
Status
Open
Summary
CARsgen Therapeutics Corporation was cited for significant current good manufacturing practice (CGMP) violations in the production of two investigational CAR T cell therapies: CT053 (anti-BCMA) and CT041 (anti-claudin 18.2), which were being used in Phase 2 clinical studies. An FDA inspection conducted in late November 2023 documented that the company's manufacturing methods, facilities, and controls failed to meet CGMP requirements under 21 CFR parts 210 and 211, rendering the products adulterated. The violations constitute prohibited acts under the Federal Food, Drug, and Cosmetic Act, as the adulterated products were held for sale and introduced into interstate commerce.
CARsgen Therapeutics Corporation FDA Warning Letter, July 26, 2024
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