FDA Expects Drug GMP Warning Letter Tally To Reach 90 This Year
OTC Firms Lacking GMP Basics Seen Driving The Surge In Warnings
FDA official says OTC firms that have not been inspected before and have limited to no knowledge of US GMP requirements appear to be driving the upward surge in drug GMP warning letters issued by the agency since January. One especially “scary” warning letter trend is manufacturers not testing incoming ingredient for diethylene glycol (DEG) or ethylene glycol (EG). Over the years, DEG contamination in pharmaceuticals has resulted in lethal poisoning incidents around the world.
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Commissioner Scott Gottlieb and CDER Director Janet Woodcock say in joint statement that patients can be confident generics are safe and effective and recent media reports misinterpreted inspection and other data when suggesting the contrary.
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