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FDA Publishes Small Entity Guide For Supplement GMPs

This article was originally published in The Tan Sheet

Executive Summary

FDA publishes good manufacturing practices guidance for small businesses making dietary supplements nearly six months after the deadline for compliance with the GMP final rule.

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GMP violation warnings to three small dietary supplement firms in late March reflect a “thoughtful shift” by FDA toward inspections of smaller firms, says UNPA President Loren Israelsen. With the supplement GMP final rule past its 10-year anniversary, firms should be meeting their requirements.

GMPs Send Smaller Supplement Firms Into Contract Manufacturers’ Arms

FDA enforcement of the good manufacturing practices final rule causes some in the supplement industry to question whether small and medium-sized firms can manufacture in-house successfully. Meanwhile, third-party manufacturers are realizing the benefits of a tighter regulatory environment.

GMPs Send Smaller Supplement Firms Into Contract Manufacturers’ Arms

FDA enforcement of the good manufacturing practices final rule causes some in the supplement industry to question whether small and medium-sized firms can manufacture in-house successfully. Meanwhile, third-party manufacturers are realizing the benefits of a tighter regulatory environment.

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