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Enforcement in Brief

This article was originally published in The Gold Sheet

Executive Summary

FDA and PIC/S inspection approaches are evolving, with FDA focusing on beta-lactams, CMOs and contract labs; and PIC/S working on inspection sharing, harmonizing on deficiencies, data integrity guidance and inspector training. Meanwhile, Dr Reddy’s gets warning letter, AstraZeneca sees EU noncompliance and four firms added to FDA’s drug GMP import alert.

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