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FDA Warns Foreign Personal-Care Firms For Monograph, GMP Violations

This article was originally published in The Rose Sheet

Executive Summary

An August letter to Jabones Pardo is the latest in a string of FDA warnings to international firms that market personal-care products for acne treatment, pain relief and other indications in violation of U.S. drug regulations. Warnings to OTC product firms outside the U.S. over the past two years reflect the higher priority FDA has assigned to inspecting international firms.

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