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

Source: https://www.keypedia.com/records/warning_letter/ole-smoky-candy-kitchen-factory/2ac8b923-bbd0-4ea4-996d-db488bc4e11a

> FDA WARNING_LETTER for Ole Smoky Candy Kitchen Factory on March 29, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ole Smoky Candy Kitchen Factory
- Inspection Date: 2021-03-29
- Product Type: Food
- Office Name: Office of Human and Animal Foods Operations - East
- Summary: 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 (

## Related Officers

- [District Director at FDA](https://www.keypedia.com/people/steven-barber/e766c0f7-0002-400f-b83a-a0a6efbf259c)

Company: https://www.keypedia.com/companies/ole-smoky-candy-kitchen-factory/99f60d4a-3d38-4cfd-82e2-5c1fd051c63d

Office: https://www.keypedia.com/offices/office-of-human-and-animal-foods-operations-east/f35344fc-4cf2-4605-b1cf-163d65050588