Andy Swenson is a dietary supplement industry professional with emphasis on quality system development. He has a wealth of experience navigating the 21 CFR Part 111 dietary supplement regulations and the FDA. Having “grown up” in the industry with the implementation of DSHEA in the mid-90’s, he has been involved in its maturation and helped many companies understand how to mitigate evolving regulatory risk.Andy specializes in FDA remediation (resolving observations from 483s and Warning Letters and communicating with the FDA). Many companies lack this expertise and find themselves in difficult situations when going through FDA inspections. Because of his experience, Mr. Swenson is often called at a moment’s notice to assist in these inspections or write responses. After dozens of 483 and warning letter responses, he has helped companies avoid further FDA enforcement action and move forward with their business.Being proactive and resolving issues before the FDA inspects a facility is always the best approach. To this end, Andy has designed and implemented virtually every quality system required by the 21 CFR Part 111 and 21 CFR Part 117 regulations for any business model. Additionally, he has successfully defended these systems in many FDA inspections. Because of this experience, Mr. Swenson understands how to design quality systems that meet FDA expectations while maintaining a realistic perspective so that business is postiviely affected.Having more than 25 successful years of industry experience gives Andy an edge when resolving conflict with the FDA and designing, creating and implementing 21 CFR Part 111 and 21 CFR Part 117 compliant systems or regulatory training. Whether it’s long term goals or short-term opportunities, he helps companies move forward through growing pains and regulatory pitfalls so that they can confidently provide safe and regulatory compliant product while balancing the realities of running a business and reducing risk.