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AHPA: Citing Regulations In Form 483s Would Boost GMP Compliance

This article was originally published in The Tan Sheet

Executive Summary

FDA investigators should cite specific regulations related to each good manufacturing practice violation uncovered during an inspection to increase transparency, understanding and compliance, the American Herbal Products Association argues in a citizen petition. Other trade groups agree it is a good idea, but NPA doubts it will boost compliance, which falls on industry before an inspection.

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