(571) 447-5500

How to Successfully Respond to FDA 483s and Warning Letters

EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how to respond in a way to prevent the issuance of a Warning Letter.”

FSMA and Dietary Supplements

By Charles Breen, EAS Senior Advisor for FSMA Consulting Services FSMA’s preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements (DS) from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR...