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Ole Smoky Candy Kitchen Factory's chocolate confection manufacturing facility in Gatlinburg, Tennessee was found to have produced adulterated ready-to-eat products prepared, packed, and held under insanitary conditions that could have become contaminated with filth or rendered injurious to health. During an FDA inspection in March 2021, investigators identified serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR 117, including failure to prepare and implement required hazard analysis and preventive controls. The company's response submitted in April 2021 was deemed inadequate to address the agency's concerns regarding compliance with preventive controls provisions.