FDA WARNING_LETTER - Nordimex, LLC - May 31, 2011

The FDA conducted an inspection of Nordimex, LLC from May 12 to May 31, 2011, revealing serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111).

Multiple products, including Leche de Alpiste, Angin Original Formula, and Broncolin Plus, are deemed unapproved new drugs under section 201(g)(1)(B) of the Act due to therapeutic claims on their labeling and website, indicating intent for disease treatment or prevention. These products are not generally recognized as safe and effective, making them "new drugs" requiring prior FDA approval (section 505(a)). Furthermore, several products are misbranded under section 502(f)(1) because they address conditions not amenable to self-diagnosis, lacking adequate directions for layperson use.

Even if not classified as drugs, the products are adulterated and misbranded dietary supplements. CGMP violations include failure to establish specifications for labels and packaging (21 CFR 111.70), and lack of quality control operations for components, packaging, and labels (21 CFR 111.120). The company also failed to establish written procedures for subpart G, specifically regarding label handling (21 CFR 111.153).

Misbranding violations