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Our analysis of 85 drug product warning letters posted in 2025 reveals the patterns: supplier qualification gaps, quality units without real authority, validation programs that stopped at Stage 2, and data integrity failures that suggest deeper cultural problems
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Fourier-transform infrared (FTIR) spectroscopy showed characteristic bands at 2558.3 cm −1 (S-H thiol stretch), 1724.2 cm −1 (C=O carboxylic acid stretch), and 1644.1 cm −1 (amide stretch)
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