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Canadian companies handling FDA-regulated goods that will be shipped to the U.S. may wish to check out a new technical guide available from Veriteq Instruments. The Richmond, B.C.-based company has produced a 10-step guide called “How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments.” It 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. 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. The document also covers food-related concerns reflected in FDA Letters of Warning. To obtain a copy of the Guide fill out the request form.
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