FDA WARNING_LETTER - Heartland Products, Inc - May 09, 2011

On May 3-9, 2011, the FDA inspected Heartland Products, Inc.'s food manufacturing facility in Des Moines, IA. The inspection revealed several violations, leading to a Warning Letter.

**Adulteration Violations:** * **Unsafe Food Additive:** Products contained industrial-grade (b)(4) and exceeded the permitted amount (2.05 grams per 100 pounds of flour) for food-grade (b)(4) as per 21 CFR 172.806. An impurity, cyanuric acid, was also found. * **Current Good Manufacturing Practice (CGMP) Violations (21 CFR Part 110):** * Failure to clean food-contact surfaces frequently (21 CFR 110.35(d)): A blender and scoops used for ingredients were not cleaned regularly and had caked-on material. * Failure to store raw materials to prevent contamination (21 CFR 110.80(a)(1)): Open ingredient bags/boxes were on the floor, and allergens were not separated. * Failure to store cleaned equipment to protect food-contact surfaces (21 CFR 110.35(e)): Clean buckets were stored uncovered near waste.

**Misbranding Violations (21 U.S.C. § 343):**