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Veriteq Instruments Inc.

FDA Compliance

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”

Published: Friday, February 12, 2010 - 11:06

(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.

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.

“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,” says Ken Appel, Veriteq vice president of regulated markets. “Since Veriteq offers the only monitoring system that ensures both gap-free records and accuracy in-between calibration intervals, we have always had customers who came to Veriteq because they were using inferior solutions. Customers are often disappointed over the failure of chart recorders or data loggers to record data during facility power outages, sensors that do not hold thier calibration accuracy, and other equipment failures that trigger 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.”

Veriteq’s guide—“How to Avoid and Respond to Public FDA Criticisms-Form 483 Letters-for Temperature, Humidity and other Controlled Environments” will help quality departments that have received such public criticism regroup, but more important, will give some best-practice tips that will help FDA-regulated organizations avoid warning letters in the first place.


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Veriteq Instruments Inc.’s picture

Veriteq Instruments Inc.

Veriteq Instruments Inc. began in 1994 with an original focus that remains today: providing the most accurate environmental monitoring, alarming, and validation solutions to the pharmaceutical, biotechnical, medical, aerospace/defense, and calibration industries.