Managing an FDA inspection is in itself a difficult task, but what should you do when an FDA investigator wants to take photographs at your facility? Whether it is pest sightings, equipment issues, or poor employee practices, the investigator has been trained by FDA to document situations such as these with photographs which can be used… Read More
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout North America, Asia-Pacific, UK and EU, EAS Consulting Group was established as an independent company in October 2006. Prior to that, it was a division of Kendle Regulatory Affairs (formerly known as AAC Consulting Group).
Recent Issue of the Month Articles
You say color, I say colour. You say "dietary supplement", we, legally, say "food supplement." And of course, the French say "complément alimentaire," the Danish say "Kosttilskud" and the Italians say "Supplemento Alimentare." With 27 different Member States within Europe, there are many more ways to say "Food Supplement." Although the languages may not be… Read More
Recent Blog posts
EAS Senior Adviser John Bailey is featured in an article titled Regulatory Roulette: Playing In Today’s Skin-Care Market A Gamble, posted online March 17 by The Rose Sheet. Recent FDA warning letters to skin-care firms raise questions about the regulatory risks companies must assume to compete effectively in the marketplace. Bailey discusses the strategic decision… Read More
by: Robert Lake, Senior Consultant While it has always been lawful to add food allergens as ingredients to human food, the Food Allergy Labeling and Consumer Protection Act (FALCPA) added section 403(w) to the Food Drug and Cosmetic Act (FD&C Act) in 2004 to specify the label declaration requirements for major food allergens. FALCPA also… Read More
by Dan Okenu, Ph.D. FSMA is the most comprehensive statutory food safety reform since the Food Safety & Cosmetic Act of 1938. This new rule empowers the FDA with a radical shift in focus towards a more proactive science and risk-based prevention strategy, and promises to raise the bar on food safety regulatory compliance for the… Read More