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Manufacturing Compliance Updates In Brief: Dasan, Akorn, Evertogen And 10 Others

 
• By Joanne S. Eglovitch

Dasan didn't test glycerin for DEG; Akorn didn't see the problem with washed-vial conveyor belt crumbs; Evertogen was undone by a desk audit; six unsanitary compounders were warned; four firms were hit with drug GMP import alerts.

Warning Rubber Stamp

FDA on Sept. 22 issued a warning letter to Dasan E&T Co., an OTC maker of creams and soaps in Gimpo, South Korea, for inadequate testing of raw materials and poor control over the manufacturing process.

The firm did not test each lot of glycerin from a supplier for diethylene glycol (DEG) or ethylene glycol (EG) before adding the raw material to drug product

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