FDA WARNING_LETTER - Elmec Industries, Inc. - March 12, 2015

An FDA inspection of Elmec Industries, Inc. (FEI: 2618913) in Mayaguez, Puerto Rico, conducted on March 2, 4, 9, and 12, 2015, found that their "Cedé Pudin" and "Cedé Lite Baked Caramel Custard" products were misbranded under 21 CFR Part 101 and Section 403 of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Undeclared Major Food Allergens:** "Cedé Pudin" (3oz and 20oz) labels failed to declare wheat and soy as major food allergens, violating Section 403(w) of the Act. 2. **Misleading Nutrient Content Claim:** "Cedé Lite Baked Caramel Custard" used the "lite" claim without meeting the requirements of 21 CFR 101.56(b). The label did not declare the reference food, the percentage of calorie/fat reduction, or quantitative comparison information. 3. **Incomplete Ingredient Lists:** All products lacked complete ingredient lists, violating 21 CFR 101.4. Examples include missing "Maltodextrin," "evaporated milk," and "Potassium Sorbate" on "Cedé Pudin" (20oz), undeclared sub-