Consent Decrees Are Last “Dance” For Supplement GMP Violators

26 Nov 2012

• By Lisa Gillespie

Consent decrees allow time for a firm to make changes with the goal of re-opening, but not without costly updates to systems and equipment and retaining a consultant and attorneys, food and drug attorney Tony Young says.

Operating under a consent decree is a “dance with the devil,” but it is the last chance for dietary supplement manufacturers to stay in business if they fail to satisfy FDA about compliance with good manufacturing practices, according to food and drug attorney Tony Young.

At SupplySide West in Las Vegas on Nov. 7, Young advised supplement firms about responding after FDA notes GMP violations...