Jun 25, 2016 | Medical Devices, White Paper
FDA reviews, evaluates, verifies and validates the implementation of the design control requirements described in the device premarket applications (510k/ PMA). Design control requirements play a key role from the device design prototype, the manufacturing process to …
Jun 22, 2016 | Foods, White Paper
This White Paper provides an analysis of FDA’s final regulation amending the Nutrition Facts label, focusing on FDA’s new requirement for added sugars content disclosure and disclosing a %DV for added sugars. The impacts of other provisions of the final rule related to the …
Jun 6, 2016 | Drugs, On Demand Webinar
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.”
Jun 1, 2016 | Foods, FSMA Perspective
FDA has now released its seventh FSMA rule – on intentional adulteration. Published May 27 in the Federal Register, the rule requires registered food facilities to develop a written food defense plan to address intentional adulteration. In an approach similar to...
Jun 1, 2016 | Dietary Supplements, Issue of the Month
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...