FDA sends letter to Novartis over Kymriah manufacturing safety concerns
The FDA on Tuesday released a new untitled letter, sent in August to Novartis, after the agency’s inspectors found new and significant issues with how Kymriah, the first-ever FDA-approved CAR-T cell therapy, is made at the company’s Morris Plains, NJ, site.
While the FDA said it already issued a Form 483 outlining some of its early thoughts on the late 2022 inspection, and received responses from Novartis, the agency says it’s now identified “additional significant deviations” upon further review of the information collected during that inspection.
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