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FDA Enforcement Priorities Include Globalization Threats

This article was originally published in The Tan Sheet

Executive Summary

FDA will overhaul its enforcement approach to reflect the impact of globalization by partnering more with foreign counterparts, streamlining inspections, recalls and emergency responses and using stiff criminal sanctions to deter noncompliance, agency officials say.

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FDA Foreign Inspections Capture Monograph, GMP Violations

An August letter to Jabones Pardo follows a number of FDA warnings to international firms that market products in the cosmetics and personal care space and violate 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.

FDA Foreign Inspections Capture Monograph, GMP Violations

An August letter to Jabones Pardo follows a number of FDA warnings to international firms that market products in the cosmetics and personal care space and violate 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.

Enforcement In Brief

GMP violations lead to prison time; Syntec supplements seized; FDA warns NanoLiposomal Nutritionals; and more Enforcement In Brief.

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