How to Respond to (and Avoid) FDA 483s

Overview:

This article shows excerpts from recent 483s issued for deviations tracking in tracking and recording environmental parameters in various applications and facilities. The article outlines ten best practices of a 483 response, providing a checklist to make the15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.

Author: Veriteq, a Vaisala company

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