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European Inspections Present New Challenges to U.S. Manufacturers

This article was originally published in The Gold Sheet

Executive Summary

DANGEROUS CONVERSATIONS are at the heart of a European inspections process that fundamentally differs from FDA’s approach. There is little guidance about the process, which is geared toward reaching conclusions rather than building a case. The European Union inspectors are more experienced, less by-the-book, more likely to chat with workers on the shop floor, experts say. Their inspections tend to be quicker, and can vary by their country of origin

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