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In the warning letter, FDA includes several repeat observations from 2022, including discoloration on equipment in the ISO 5 area, monitoring environmental conditions in aseptic processing areas, and failure to establish and follow appropriate written procedures to prevent microbiological contamination

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1 Tolerability Semaglutide is generally well tolerated with similar dropout rates when compared with placebo, although it may be less well tolerated than dulaglutide (Trulicity)

the nutritional changes that occur during treatment are usually the main driver

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