FDA WARNING_LETTER - Altura Food, Inc. - June 29, 2012

The FDA conducted inspections of Altura Food, Inc.'s pasteurized fruit juice beverage manufacturing facility in Ciales, Puerto Rico, on multiple dates in March, April, and June 2012. The inspection revealed that several products, including AFI Fruit Punch and V-100 Apple Carrot, Cranberry, and Orange Juice, are misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101.

Key violations include: 1. **Standard of Identity:** V100 Orange Juice is misbranded because it contains ascorbic acid, which is not permitted by the standard in 21 CFR 146.145 for orange juice from concentrate, without proper fortification disclosure. 2. **Common or Usual Name:** AFI Fruit Punch and V100 Apple Carrot, Cranberry, and Orange Juice lack adequate common or usual names. Specifically, V100 Cranberry Juice (27% juice, predominantly apple juice) is labeled simply as "Cranberry Juice" and fails to indicate it's less than 100% juice, that cranberry is not the only juice, or that cranberry is present as a flavor. Additionally, "from concentrate" declarations are missing or improperly placed/sized on AFI Fruit Punch and V100 Apple Carrot, Cranberry, and Orange Juice labels. 3. **Ingredient Declaration