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Home » Crafting Effective Responses to FDA Form 483 Can Ease Pain of Inspectional Observation
Crafting Effective Responses to FDA Form 483 Can Ease Pain of Inspectional Observation
February 7, 2005
Companies that deliver prompt, convincing responses to an FDA Form 483 observation can minimize the impact of a negative assessment, according to a consultant, who added that communications failures early in the process can lead to serious enforcement actions against an offending firm.