The Rocky Mountain Dietary Supplement Forum held a successful 1.5 day seminar in Boulder, Colorado, September 13-14.  The event hosted several speakers and a panel composed of industry executives and quality managers who spoke about their firms’ experiences during FDA inspections.  Delegates heard from FDA Denver District representatives what they expect during an inspection, and learned how to dramatically change the outcome of their inspection.  Attendees received step-by-step instructions and templates on how to respond to 483s and Warning Letters.  We also heard about record keeping, labeling, and testing issues frequently found during inspections and reviews at dietary supplement manufacturers and distributors.  The meeting gave speakers and guests alike the opportunity to interact with other industry professionals who are facing the same challenges.  The organizers hope that the forum will become an annual event. [see update]

Speakers: Nancy Schmidt, Compliance Officer, and Devin Koontz, Public Affairs Specialist, Denver District FDA;  Justin and Jim Prochnow, Shareholders, Greenberg Traurig LLP; James Neal-Kababick, Founder & Director, Flora Research Laboratories; Cindy Beehner, Owner, QSD Consulting; Mollie Kober, Auditor, and Lisa Thomas, Business Unit Manager, Dietary Supplements and Sports Nutrition, NSF International; Shelly Maifarth and Martina LaGrange, FDA Compliance Group, LLC; Marian Boardley.  Industry Panel: David Hinton, President & CEO, Nelson Bach (USA) ; Doug Robertson, Director, Quality & Compliance, Rhema Health Products Ltd.; Teressa Street, Director of Quality, 4Life Research.

The event was sponsored by Nu Skin Enterprises and NSF.

Press Coverage:

Good 483 responses can squelch warning letters

Have a game plan for GMP inspections, experts say

GMPs: Lack of records starting to sound like broken record

Keep CEOs on short leash during GMP inspections, experts say