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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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Additionally, large-scale real-world studies indicate that GLP-1 class drugs may cause severe adverse reactions, such as acute pancreatitis, cholelithiasis, and acute kidney injury [[32], [33], [34], [35]]