FDA EIR - VMN LLC DBA VM Nutritional - June 15, 2015

An FDA inspection of VM Nutritional, Inc., a manufacturer of liquid dietary supplements and fruit juices in Murray, UT, was conducted from June 4 to June 15, 2015. This initial inspection aimed to evaluate the firm's compliance with dietary supplement and Juice Hazard Analysis and Critical Control Point (HACCP) Good Manufacturing Practices (cGMPs), following up on two consumer complaints. The regulatory framework for the inspection included CP 7321.008 (Dietary Supplements) and CP 7303.847 (Juice HACCP Inspection Program). The inspection revealed four main violations documented on an FDA-483 form. The company failed to conduct appropriate tests to verify the identity of dietary ingredients prior to use and did not establish product specifications for the identity, purity, strength, and composition of finished dietary supplements. Additionally, for a specific juice product, the firm lacked a written hazard analysis to determine potential food hazards and did not have a written HACCP plan, violating 21 CFR 120.7(a) and 21 CFR 120.8(a). VM Nutritional, Inc. was required to submit a written response within 15 business days. Management indicated their intent to establish a trained HACCP team and develop the necessary hazard analysis and HACCP plan for the juice product by July 2015. The FDA also informed the company of potential sanctions, including warning letters, seizure, and injunctions.