FDA WARNING_LETTER - Flanes Lymar - June 11, 2012

An FDA inspection of Flanes Lymar's food manufacturing facility in Ponce, Puerto Rico, conducted on May 29-30 and June 4, 11, 2012, revealed significant misbranding and Current Good Manufacturing Practices (cGMP) violations.

The Flan de Coco, Cheesecake, and Tres Leches Lymar products were found to be misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act). Violations included failure to declare major food allergens (eggs, milk, coconut, wheat, soy) as required by Section 403(w), failure to bear the common or usual name of the food (Flan de Coco), incomplete ingredient lists with sub-ingredients (21 CFR 101.4), and incomplete declaration of manufacturer/distributor name and place of business, and net quantity of contents (21 CFR 101.5, 101.105).

Repeat cGMP violations, causing products to be adulterated under Section 402(a)(4) of the Act, included inadequate pest exclusion (insects, lizard, flies, mosquitoes observed), insufficient hand-washing facilities and poor employee hygiene, unsanitary building conditions (chipped paint above products), improper fan operation (dusty fans blowing over unprotected products), inadequate protection against microbial growth (unrefrigerated caramel), and improper equipment cleaning (dirty