A ten-step technical guide, “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 manufacturer of FDA-compliant environmental monitoring, alarming, reporting, and temperature/humidity technology.
The ten-step guide is designed to help the wide range of pharmaceutical processors, medical device manufacturers, and other GxP facilities that 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. This affects all packagers and converters worldwide who produce packaging for FDA-regulated products sold in the US.
Ken Appel, Veriteq VP Regulated Markets, comments, "Customers are often disappointed over the failure of chart recorders or data loggers to record data during facility power outages, hold calibration accuracy of sensors, or other equipment failure that had triggered negative FDA actions or product loss. If and when a company receives a Warning Letter, it is a matter of public record listed on the FDA's web site. This guide will help quality departments that have received such public criticism regroup, but more importantly, will give some best-practice tips that will help FDA-regulated organizations avoid Warning Letters in the first place."
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