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, and the hard truth that many quality managers in pharmaceutical processing plants think they are in compliance when they are not. For example, many find out during an FDA audit that they were missing data in controlled environments because their instrumentation was unable to record data during facility power outages or network downtime. “How to Avoid and Respond to FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments” is now available from Veriteq, (http://www.veriteq.com/fda_response.htm — a 10-step Guide designed to help pharmaceutical processors who may receive warning letters to respond quickly and appropriately within the permitted 15-day window.
