New England Confectionery Company, Inc. – FDA Warning Letter, Dec 14, 2017

On May 16, 2018, the FDA issued a Warning Letter to New England Confectionery Company, Inc. following an inspection from November 13 to December 14, 2017. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to the determination that the company's candy products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Pest Exclusion (21 CFR 117.35(c)):** Extensive rodent activity was observed throughout the facility, including numerous rodent excreta pellets (REPs) on raw materials, finished product components, and various storage and production areas. Rodent urine stains, gnaw holes, and nesting material were also found. A dead rodent was observed in the parking lot. These were repeat observations from a previous inspection (June 7-12, 2017), and exterminator reports indicated active infestation. 2. **Sanitary Facility Maintenance (21 CFR 117.35(a)):** Unknown liquid was dripping from a ventilation duct onto exposed ready-to-eat products. Standing puddles from roof leaks were observed in shipping/receiving and finished product storage areas, with forklift tracks leading into raw