FDA WARNING_LETTER - Omega Nutrition U.S.A., Inc. - December 21, 2010

The FDA conducted an inspection of Omega Nutrition U.S.A., Inc.'s dietary supplement manufacturing facility in Bellingham, Washington, on December 6-7 and 21, 2010. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), causing EB Capsules to be adulterated. Additionally, labels for EB Capsules and Flax Oil Capsules were found to be misbranded under section 403 of the Act.

Significant violations include: 1. **Dietary Supplement CGMP:** Failure to prepare and follow a written master manufacturing record for each unique formulation and batch size, as required by 21 CFR 111.205(a). The "Recipe Calculator Sheet" for EB Capsules lacked required specifications and controls (21 CFR 111.205(b), 111.210). 2. **Misbranding:** Labels for EB Capsules and Flax Oil Capsules failed to identify the products using the term "dietary supplement," violating section 403(s)(2)(B) of the Act and 21 CFR 101.3(g). 3. **Unapproved New Drugs:** Claims on the company's website (www.omeganutrition.com) for products like Hi-Lignan Nutri-Flax Capsules, Essential Balance Capsules, and