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Door-Opener for Inspections: Guidance Lists Unacceptable Tactics To Hamper FDA Visits

This article was originally published in RPM Report

Executive Summary

FDA has a powerful new tool to assure access to drug manufacturing plants: legislated authority to deem a product adulterated when a company tries to evade inspections: A new guidance elaborates on the situations that FDA will define as obstructionist, and cuts into new territory by defining refusal to provide records in lieu of an inspection as an actionable offence.

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