FDA WARNING_LETTER - Ole Smoky Candy Kitchen Factory - March 29, 2021

The FDA inspected a chocolate confections manufacturing facility at 642 Ski Mountain Road, Gatlinburg, TN, from March 15-29, 2021, and issued a Form 483. 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), deeming the ready-to-eat chocolate products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include the failure to prepare and implement a comprehensive food safety plan, as required by 21 CFR 117.126(a)(1). Specifically, the facility did not conduct a hazard analysis for allergen cross-contact, undeclared allergens (peanuts, tree nuts, milk, egg, wheat), bacterial pathogens (Salmonella in peanuts/tree nuts), environmental pathogens (Salmonella in RTE food exposed to environment), and mycotoxins (aflatoxin in peanuts/tree nuts), as required by 21 CFR § 117.130(a). The facility also failed to identify and implement preventive controls to minimize or prevent identified hazards (21 CFR § 117.135(a)(1)).

Additionally, the facility did not adequately maintain equipment and food-contact surfaces to prevent allergen cross-contact and contamination (