Ole Smoky Candy Kitchen Factory

Warning LetterOpen

Patricia Edwards President Ole Smoky Candy Kitchen Factory 744 Parkway Gatlinburg , TN 37738 United StatesFEI 3005369601Issued Jul 30, 2021Office of Human and Animal Foods Operations-East

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005369601.

Violations4

Issue DateJul 30, 2021

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Ole Smoky Candy Kitchen Factory
Location: Patricia Edwards President Ole Smoky Candy Kitchen Factory 744 Parkway Gatlinburg , TN 37738 United States
FEI Number: 3005369601
Country: United States
Issue Date: July 30, 2021
Issuing Office: Office of Human and Animal Foods Operations-East
Product Type: Food & Beverages
Status: Open

Summary

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.

Ole Smoky Candy Kitchen Factory FDA Warning Letter, July 30, 2021