The final webinar as part of the EAS presented series for CHPA’s OTC Academy will take place on April 17, 2018, at 2 pm when Independent Advisor for Quality and Compliance Robert Fish, will discuss Responding to 483s and Warning Letters. Fish says that it is extremely important to promptly respond to any correspondence from FDA, particularly the FDA-483 or a Warning Letter. If a foreign firm receives a Warning Letter from FDA the company will most likely be placed on an Automatic Detention list which means that none of their products will be permitted entry into the U.S. until the issues are corrected and FDA has verified the corrections. This webinar will explain the FDA processes and provide guidance on how to manage these issues.
Posted in Drugs, EAS in Action.