Out of the Lab: Operationalizing Cell and Gene Therapy
You Can’t Test Quality Into a Product: FDA Import Alerts & GXP with Wynngate Consulting
What happens when a foreign manufacturer gets put on an FDA import alert? Or when a single undocumented ingredient turns a harmless dietary supplement into an unapproved drug? In this episode of Out of the Lab , host Nico sits down with Dan and Binh from Wynngate Consulting. Bringing decades of insider FDA experience from compliance enforcement to foreign facility inspections, they pull back the curtain on the operational realities of GXP manufacturing. We explore the massive regulatory shifts brought on by the Food Safety Modernization Act (FSMA) and why the FDA's Foreign Supplier Verification Program has changed the game for importers. In this episode, we cover: The Overlapping 50%: The surprising similarities and critical differences between dietary supplement GMPs (Part 111) and pharmaceutical GMPs (Part 211). The "Checking the Box" Trap: How an inadequate response to an FDA 483 observation can escalate into an Import Alert and a 10-year remediation nightmare. Intentional vs. Accidental Adulteration: From shared line cross-contamination to companies secretly lacing weight-loss supplements with active pharmaceuticals to dodge clinical trials. The Old FDA Adage: Why you can never test quality into a product once underlying GMP violations exist. Supply Chain Resilience: Why vetting your foreign CDMO's quality management system is the ultimate risk mitigation technique for drug sponsors. Dan and Binh consult on GxP compliance at Wynngate Consulting.Connect with them: Dan Simonsen, Vice President: https://www.linkedin.com/in/danjsimonsen/ Binh Nguyen, President: https://www.linkedin.com/in/binh-nguyen-a77046190/ Visit their website:https://www.wynngateconsulting.com/
