Jul 8, 2024 | Foods, Issue of the Month
Import Refusals – “Don’t Panic” By Mark Moen, EAS Consulting Group Senior Regulatory Consultant Products imported into the US may be assessed and inspected by US Customs and Border Protection (CBP), the Food and Drug Administration (FDA), and US Consumer Products...
Jun 17, 2024 | Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month
Product Claim Substantiation By Jay Ansell, EAS Independent Consultant Substantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade...
May 2, 2024 | Issue of the Month, Medical Devices
Quality Management System (QMS) Documentation By Jeff VanderHoek, EAS Independent Consultant The design and manufacturing of medical devices requires a high level of quality and reliability to ensure patient safety and regulatory compliance. The Quality Management...
Apr 3, 2024 | Foods, Issue of the Month
Control of Cronobacter in Dairy Dryer and Packaging Rooms By Beth Koenig, EAS Independent Consultant What Is Cronobacter and Why Should We Be Concerned About It? Cronobacter, a genus of bacterial pathogens in the Enterobacteriacea family is of considerable concern in...
Mar 5, 2024 | Issue of the Month
Are You Ready for the Unspoken Challenges of FSMA 204? By Norman Alayan, EAS Independent Consultant “The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability record-keeping...
Feb 1, 2024 | Issue of the Month, Medical Devices
The Importance of the Medical Device Single Audit Program (MDSAP) and EU MDR Lead Auditor Certifications By Kevin Walls, MBA, EAS Independent Consultant The Medical Device Single Audit Program (MDSAP) is a certification program many medical device manufacturers are...
