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How to Avoid FDA 483s for Temperature, Humidity and other Controlled Environments

Wed, 10/17/2012 - 3:10pm
Vaisala

This article shows excerpts from recent 483s issued for deviations in tracking and recording environmental parameters in various applications, then outlines ten best practices of a 483 response, providing a checklist to make the 15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.

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