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Basic GMP Failures Will Prompt Heightened FDA Scrutiny

This article was originally published in The Tan Sheet

Executive Summary

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.

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In Brief

Kabco to stop production until GMPs met; ginkgo is not a food additive, FDA warns; more spiked sexual enhancement supplements recalled; SmartShield expands civilian distribution; P&G advances toward zero-waste goals; Sanofi opens Vietnam facility; Carlson doubles capacity.

FDA Will Crack Down On GMP Ingredient, Contaminant Spec Requirements

GMP inspectors will begin more aggressively enforcing requirements for ingredient and contaminant specifications, FDA’s Fabricant warns. Recalls for undeclared allergens, salmonella and other pathogens are emerging more frequently as well.

FDA Will Crack Down On GMP Ingredient, Contaminant Spec Requirements

GMP inspectors will begin more aggressively enforcing requirements for ingredient and contaminant specifications, FDA’s Fabricant warns. Recalls for undeclared allergens, salmonella and other pathogens are emerging more frequently as well.

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