FDA WARNING_LETTER - Heartland Gourmet, LLC - March 20, 2013

On March 18-20, 2013, the FDA inspected Heartland Gourmet, LLC's manufacturing facility in Lincoln, NE, finding significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the manufactured foods adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specific violations include: 1. **Pest Exclusion Failure (21 CFR 110.35(c)):** Evidence of numerous live and dead insects was found in and on food contact surfaces of dry goods manufacturing equipment, including a small mixer and a plastic tub of flour. 2. **Equipment Design and Construction Deficiencies (21 CFR 110.40(a)):** Manufacturing equipment, including large and small dry mix mixers, a hopper, and packaging equipment, had rough, pitted, and stained seams, and clear plastic tape was used to cover joints, seams, and bad welds, precluding proper cleaning and potentially contaminating food. 3. **Inadequate Cleaning of Food-Contact Surfaces (21 CFR 110.35(d)):** Equipment identified as "clean" had significant product residue buildup, rough welds, pitted/stained seams, and un-cleanable surfaces due to plastic tape. A vinyl sleeve on