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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.