Paramount Muffins, LLC – FDA Warning Letter, Jun 10, 2011

On May 31, June 2-3, and June 10, 2011, the FDA inspected Paramount Muffins, LLC, located at 61 Davenport Ave., Newark, NJ. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110), causing products like "Sweet City" muffins and cakes to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. **Improper handling of work-in-process:** Ready-to-eat products were exposed to the street, flies, and a filthy exhaust fan. Cooling products were under a fly strip with numerous dead flies. Icing was near a mixer encrusted with residue and live insects. 2. **Inadequate hygienic practices:** An employee touched a hopper, scratched and wiped his nose, then handled chocolate chips and filled muffin pans without washing hands or using gloves. A bakery employee wore heavily soiled street clothes during production. 3. **Insufficient hand-washing facilities:** No hand-washing station in the production area, and the lavatory sink lacked hot water. 4. **Infrequent cleaning of food-contact surfaces:** Packaging machine and conveyor had peeling paint, food residue, and apparent rodent excreta pellets (REPs). Utensils cleaned in a single-compartment sink were stored on