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FDA Expects Drug GMP Warning Letter Tally To Reach 90 This Year

OTC Firms Lacking GMP Basics Seen Driving The Surge In Warnings

 
• By Joanne S. Eglovitch

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.

Warning Rubber Stamp

Manufacturers of over-the-counter drugs that have not been inspected before are accounting for an upward surge in drug GMP warning letters issued this year. Many of these firms appear to lack basic knowledge of GMPs and are not conducting finished product testing nor testing incoming ingredients.

Other warning letter trends are problems related to investigating batch failures, failures to prevent cross-contamination, and problems related to water testing. While data integrity is still a significant problem, it...

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