A guide is available to help pharmaceutical companies regulated by the US Food and Drug Administration handle public criticism warning letters within the permitted 15-day window, published by Veriteq.
Proper FDA 483 letter response is critical in reputation repair and for remedial action to assure a quality process and patient safety, says Veriteq, a maker of environmental monitoring products and a specialist in FDA compliance.
How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments, obtainable from Veriteq,
‘will give some best-practice tips that will help FDA-regulated organisations avoid warning letters in the first place,’ says Ken Appel, Veriteq vice president, regulated markets.
