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Product News: Technical Guide for U.S. FDA-Regulated Organizations

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

Veriteq Instruments Inc.
Fri, 02/12/2010 - 10:06
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(Veriteq: Richmond, BC Canada) -- “How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments” is now available from Veriteq, a provider of FDA-compliant environmental monitoring, alarming, reporting, and temperature/humidity technology.

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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 to respond quickly and appropriately within the permitted 15-day window. Proper FDA 483 letter response is critical for helping repair your reputation and for real remediation actions that willl 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.

 …

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