Veriteq has introduced a 10-step guide entitled 'How to Avoid and Respond to Public FDA Criticisms - Form 483 Letters - for Temperature, Humidity and Other Controlled Environments'.
The guide is designed to help 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 to help in reputation repair and for real remediation actions to assure a quality process and patient safety, according to the company.
FDA 483 letters are expected to increase this year, reflecting the Food and Drug Administration's (FDA's) recent staff expansion and rewrite of the FDA 483 letter rules to narrow the response time to the new 15-day window.
