FDA WARNING_LETTER - Fitkin Popcorn LLC - September 22, 2014

On September 22, 2014, the FDA, via the Iowa Department of Inspections and Appeals (DIA), inspected Fitkin Popcorn LLC's manufacturing facilities at 5400 Ford Rd and 3701 Ford Rd, Cedar Falls, IA. This inspection was a follow-up to a September 8, 2014, DIA inspection. The inspections revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the food adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §342(a)(4)].

Repeat violations from the September 8, 2014 inspection included: 1. Failure to take effective measures to exclude pests and protect against food contamination (21 CFR 110.35(c)). Evidence included apparent rodent and bat droppings in the storage building at 5400 Ford Rd, and rodent droppings and an insect in popcorn product at 3701 Ford Rd. 2. Failure to provide adequate screening or other protection against pests (21 CFR 110.20(b)(7)). Openings to the exterior were observed at the base of doors and the lower SW corner of the building at 3701 Ford Rd.