We can help provide tailored guidance on FDA regulations under the Dietary Supplement Health Education Act (DSHEA) and new food traceability mandates. Our services include compliance assessments of product labels, ingredients, and claims.

Our experts provide detailed reviews of product packaging, advertising, and marketing claims to assure compliance and provide recommendations for permissible structure-function claims and disclaimers.

KAI will assist you in implementing traceability systems to meet FDA’s Food Traceability requirements. We can build tailored quality tracking systems and metrics for raw materials, production, and distribution to ensure supply chain integrity. Additionally, we can assist with suppler audits and qualification programs and help you evaluate traceability software and workflows for CTEs.

Our services encompass the execution of GMP audits to ensure your compliance with 21 CFR Part 111 and 21 CFR 117, as well as to identify and rectify any discrepancies in manufacturing and quality systems prior to FDA inspections.