Technical Guide for US FDA-Regulated Organisations

Technical Guide for US FDA-Regulated Organisations 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 has bearing both for US-headquartered laboratories and international laboratories involved in making FDA-regulated products sold in the US.

Now Veriteq, a leader in FDA-compliant environmental monitoring, alarming, reporting and temperature/humidity technology offers a 10-step Guide 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. 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.

Ken Appel, Veriteq Vice President Regulated Markets, commented: "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’ 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 organisations avoid Warning Letters in the first place."

For further details visit: www.veriteq.com/fda_response.htm or contact: Janice Bennett, Tel: +1-604-273-6850