FDA WARNING_LETTER - Modern Products, Inc. - September 06, 2011

An FDA inspection of Modern Products, Inc. conducted in August and September 2011 revealed significant violations. The firm, an own-label dietary supplement distributor, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering its Fearn Lecithin Granules, Fearn Liquid Lecithin, Fearn 100% Soy Protein Isolate, and Gayelord Hauser Brewers Yeast products adulterated under section 402(g)(1) of the Act. Key CGMP deficiencies included failure to establish specifications for received products (21 CFR 111.70(f)), and a lack of written procedures for quality control (21 CFR 111.103), holding and distributing (21 CFR 111.453), and packaging and labeling operations (21 CFR 111.403). The firm also failed to package and label dietary supplements as specified in a master manufacturing record (21 CFR 111.415).

Additionally, food products, All Natural Swiss Formula Broth and Garlic Magic! Spike Gourmet Natural Seasoning, were found to be misbranded under section 403 of the Act. The Swiss Formula Broth was misbranded due to unauthorized nutrient content claims (e.g., "contains…protein," "RICH MINERAL CONTENT") not complying with 21 CFR 101.13(b) and 101.54, incorrect nutrition facts format (21 CFR 101.9), and improper serving size declaration (21 CFR 101.9(b), 101.12(b)). The Garlic Magic! seasoning was misbranded for failing to list its common or usual name (21 U.S.C. § 343(i)(1)). The FDA requires prompt corrective action within 15 working days, including a written explanation and documentation, to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction, and impact federal contracts or export certificates.