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Follow on Google News | Veriteq Guide for US FDA-Regulated Organizations Now Available “How to Avoid and Respond to PublicFDA 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.
By: Veriteq Instruments 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 Vice President 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 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, 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. Veriteq's guide-"How to Avoid and Respond to Public FDA Criticisms-Form 483 Letters-for Temperature, Humidity and other Controlled Environments" To obtain a copy of the Guide fill out the request form at http://www.veriteq.com/ About Veriteq Veriteq Instruments (www.veriteq.com) # # # Veriteq Instruments is the leader in Environmental Monitoring & Validation solutions for Temperature, Humidity and other parameters End
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