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Guide for US FDA-Regulated Organizations Now Available
Date:4/29/2010

“How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments”

(Vocus) April 29, 2010 -- “How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments” is now available from Veriteq (www.veriteq.com), a Vaisala company, a leader in FDA-compliant environmental monitoring, alarming, reporting and temperature/humidity technology. The 10-step Guide is designed to help the wide range of pharmaceutical processors, blood and tissue banks, clinical laboratories, medical device manufacturers, research hospitals, and other GxP facilities who may receive public criticism warning letters respond quickly and appropriately within the permitted 15-day window. Proper FDA 483 letter response is critical to both help in reputation repair and for real remediation actions to assure a quality process and patient safety.

FDA 483 letters are expected to increase this year, reflecting the FDA’s recent staff expansion and rewrite of the FDA 483 Letter rules to narrow response time to the new 15-day window.

Ken Appel, Veriteq Manager Regulated Markets, comments, "Veriteq is keenly aware of the great number of FDA-regulated companies that thought they were in full compliance but were not when it came to temperature monitoring. Since Veriteq offers the only monitoring system that ensures both gap-free records and accuracy in between calibration intervals we have a
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