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Basic GMP Failures Will Prompt Heightened FDA Scrutiny

 
• By Malcolm Spicer

FDA supplement programs director Dan Fabricant and food and drug law attorney Marc Ullman reflect on the ongoing struggles of many supplement firms to meet good manufacturing practice standards. “‘I don’t have the resources to comply’ is not an excuse. Then get out of the business,” Ullman says.

Widespread failure by dietary supplement firms to meet basic elements of good manufacturing practices likely will draw more attention from FDA.

Requirements in the supplement GMP final rule should be clear to all supplement manufacturers, and it has been...

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