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In the import alert text, FDA describes evaluating 48 GLP1 API sites via onsite inspections and remote assessments, and says 21% were found noncompliant under section 501 of the FD&C Act, either due to evidence of CGMP noncompliance or because firms didnt respond to FDAs records requests in time

The FDA labels for Wegovy and Zepbound, which are approved for obesity, already warn doctors to monitor patients for suicidal thoughts, while the labels for Ozempic and Mounjaro, which are approved for type 2 diabetes, dont contain that warning

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