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The Tricky Business Of Environmental Control

This article was originally published in The Gray Sheet

Executive Summary

From our digital archives: Manufacturers must keep a firm grasp on environmental controls to avoid potentially tough regulatory penalties. “Clearly environmental controls are important, and FDA will and can take major regulatory action when environmental controls aren’t being adhered to,” ex-FDA official Kim Trautman said in September 2011. Communication is cited as an important aspect for firms as they attempt to ensure that facilities meet FDA’s environmental control requirements.

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