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Manufacturing Quality Compliance

US FDA's Program Alignment: Where Should Form-483 Responses Go After May 15?

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Executive Summary

Now that FDA is aligning its enforcement program with its product centers on May 15, there are questions about who in the agency should receive manufacturers' 15-day responses to Form-483 inspectional observations.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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