FDA WARNING_LETTER - Blends Maker Mfg Inc. - April 27, 2012

On August 28, 2012, the FDA issued a Warning Letter to Blends Maker Manufacturing, Inc. following inspections of their juice and juice beverage facility in Comerio, Puerto Rico, on January 18, 23, February 2, and April 12, 27, 2012. The letter identified serious, repeat violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering their juice products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, product labels caused products to be adulterated under section 402(a)(2)(C)(i) and misbranded under section 403 of the Act, failing to comply with 21 CFR Part 101, Food Labeling regulation.

Significant HACCP violations included: 1. Lack of a written HACCP plan and hazard analysis for 100% juice products, specifically (b)(4) juice, to control reasonably likely food safety hazards (21 CFR 120.8(a)). 2. Failure to perform and document a 5-log reduction of pertinent microorganisms for (b)(4) concentrate, and to ensure this reduction and final product packaging are accomplished in their facility through direct juice treatment (21 CFR 1