DURHAM, N.C. — A Chinese biopharmaceutical company faces mounting scrutiny from federal regulators over concerns about the firm’s facility in Durham.
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The U.S. Food and Drug Administration in July sent CARsgen Therapeutics (HK) a warning letter outlining violations found during an inspection of the facility in late 2023. The company, in a public filing, says it has already submitted a response to the FDA and that it is working to address the issues.
The warning letter is an escalation of an initial report of observations that FDA investigators issued the company last year following an inspection of the facility.
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