Episode #85
What Triggers an FDA or USDA Investigation? Former FDA Official Benjamin England Explains
What actually makes a regulator decide to dig deeper, and what can make a routine inspection turn into serious enforcement action? Benjamin England, a former FDA investigator, criminal special agent, and attorney who now represents companies against the agency, joins Know Your Regulator to break down how FDA, USDA, and Customs actually think during an inspection. In this episode of Know Your Regulator, we discuss what can trigger increased regulatory scrutiny, why documentation and recordkeeping matter so much during an FDA inspection or other regulatory inquiry, and how a company’s response can influence what happens next. Benjamin also breaks down: • What regulators are looking for during an inspection • The behaviors that can raise an inspector’s suspicions • Why safety, trust, and documentation can quickly escalate a regulatory issue • How to respond when a regulator asks for information they may not be entitled to receive • FDA vs. USDA authority and how overlapping agency jurisdiction can affect businesses • Regulatory risks involving foreign suppliers and imported products • What to do when you receive a regulatory notice, records request, or notice of violation • When it may be time to involve regulatory counsel • Why written SOPs and inspection-response procedures can help protect your organization before a regulator ever arrives One of the biggest takeaways? Preparation should happen before an inspection or enforcement issue begins. Clear SOPs, organized records, properly trained employees, and a clear understanding of your regulator’s authority can help you respond thoughtfully instead of reactively. Whether you’re a licensed professional, business owner, quality assurance leader, compliance professional, or work in a highly regulated industry, our conversation offers a behind the scenes look at how regulators think, and how regulated professionals and organizations can better prepare for regulatory scrutiny. Share and subscribe to Know Your Regulator for conversations that help Texas professionals better understand the agencies, rules, investigations, and regulatory processes that can affect their careers and livelihood. _______________________________________ About Benjamin England, Esq., Founder and CEO of FDAImports: Benjamin is a former FDA official, microbiologist, and federal regulatory inspector who went on to serve as a Special Agent with the FDA’s Office of Criminal Investigations and an attorney to the FDA’s Associate Commissioner for Regulatory Affairs. Today, he advises companies at the intersection of FDA, Customs, and USDA regulations, with over two decades of experience navigating enforcement, compliance, and cross-border trade issues. He is known for his practical, behind-the-scenes insights into how food, drug, device, and cosmetic regulation actually work, and for translating complex regulatory systems into clear, actionable guidance. ____ Learn more about FDAImports, FDA consultants and advocates - https://www.fdaimports.com/ Explore FDAImport’s free resources on various FDA, USDA, and Customs regulations!- https://www.fdaimports.com/regulations/ _______________________________________ Get more information, details and resources on Know Your Regulator - https://www.bertolinolaw.com/know-your-regulator/
