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Looming GMPs Could Doom Some Firms Unless Industry, FDA Lend Support

This article was originally published in The Tan Sheet

Executive Summary

Some smaller dietary supplement firms could need support from the industry and flexibility from FDA to pay for complying with good manufacturing practices and still keep their doors open

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Basic GMP Failures Will Prompt Heightened FDA Scrutiny

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.

Basic GMP Failures Will Prompt Heightened FDA Scrutiny

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.

As Supplement GMP Implementation Hits Zero Hour, Small Firms Still Struggle

FDA's final rule for dietary supplement good manufacturing practices completed its phase-in for the industry June 25, and the agency now prepares to conduct inspections of small firms, which have struggled the most to comply with the regulation

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