Warning letter

Ole Smoky Candy Kitchen Factory: warning letter of Jul 30, 2021

FDA warning letter 614263 · Office of Human and Animal Foods Operations-East

Key facts

Reference number 614263
Company Ole Smoky Candy Kitchen Factory
Subject CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Issue date Jul 30, 2021
Posted date Aug 3, 2021
Issuing office Office of Human and Animal Foods Operations-East
Product type Food/Cosmetics
CFR sections cited 117, 117.135, 117.140, 117.126(a)(1), 117.130(a), 117.135(a)(1), 117.165(a)(3), 117.130(c)(1)(ii)
Inspection city Gatlinburg
Inspection ZIP 37738
Inspection start date Mar 15, 2021
Letter on fda.gov fda.gov

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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