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Rather than requesting procedural updates alone, FDA required: Independent data integrity investigations Interviews with current and former employees Three-year retrospective review of invalidated OOS results Comprehensive risk assessments Long-term CAPA programs Annual third-party CGMP audits Continuous oversight of microbiology testing for U.S

Individuals at risk include vegetarians, vegans, older adults, and those with gastrointestinal disorders that affect absorption

People with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) or with a personal or family history of medullary thyroid carcinoma (MTC) should not use semaglutide