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  5. Ole Smoky Candy Kitchen Factory - 614263 - 07/30/2021
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Ole Smoky Candy Kitchen Factory MARCS-CMS 614263 —

Delivery Method:
United Parcel Service
Food & Beverages

Recipient Name
Patricia Edwards
Recipient Title
Ole Smoky Candy Kitchen Factory

744 Parkway
Gatlinburg, TN 37738
United States

Issuing Office:
Office of Human and Animal Foods Operations-East

United States

July 30, 2021

Warning Letter 614263

Dear Ms. Edwards:

The U.S. Food and Drug Administration (FDA) inspected your chocolate confections manufacturing facility, located at 642 Ski Mountain Road, Gatlinburg, TN 37738 on March 15-29, 2021. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR 117). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing deviations found at your firm.

Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) chocolate products manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Codes (U.S.C.) § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's Internet home page at http://www.fda.gov.

We received your response dated April 5, 2021, which included a summary of corrective actions taken and planned by your firm. After reviewing the inspectional findings and your response to the observations listed in the FDA Form 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117, Subpart C):

1. You did not prepare, or have prepared, and implement a food safety plan as required by 21 CFR 117.126(a)(1). The preparation of the food safety plan must be overseen by a preventive controls qualified individual (PCQI) and must include the following:

(1) A written hazard analysis, as required by § 117.130(a)(2);
(2) Written preventive controls, as required by § 117.135(b);
(3) A written supply-chain program, as required by subpart G;
(4) A written recall plan, as required by § 117.139(a);
(5) Written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
(6) Written corrective action procedures, as required by § 117.150(a)(1); and
(7) Written verification procedures, as required by § 117.165(b).

2. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,

a. You did not identify and evaluate allergen cross-contact to determine whether it is a hazard requiring a preventive control. Your facility manufactures multiple products with different allergen profiles (including buckeyes and chocolate covered gummy bears) (b)(4) and on shared equipment, which can result in allergen cross-contact without appropriate controls.

b. You did not identify and evaluate undeclared allergens to determine whether they are a hazard requiring a preventive control. Your facility receives, stores, and manufactures various products that contain allergens such as peanuts, tree nuts (e.g., almonds and pecans), milk, egg, and wheat.

c. You did not identify and evaluate bacterial pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control. Your facility manufactures food with peanuts and tree nuts (e.g. almonds and pecans). These ingredients have been associated with pathogens such as Salmonella.

d. You did not identify and evaluate environmental pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control to comply with 21 CFR 117.130(c)(1)(ii). Your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen that would significantly minimize the pathogen. Note that environmental monitoring is required if contamination of a RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)).

e. You did not identify and evaluate mycotoxins to determine whether they are a hazard requiring a preventive control. Your facility manufactures/processes food with peanuts and tree nuts (e.g. almonds and pecans). These ingredients have been associated with mycotoxins such as aflatoxin.

3. You did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act, as required by 21 CFR § 117.135(a)(1). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).

In your response dated April 5, 2021, you stated that you are working toward developing a food safety plan to include written preventive controls, but you did not provide a timeline for the completion of the food safety plan. Moreover, you did not provide information regarding conducting a hazard analysis to evaluate hazards (such as undeclared allergens, pathogens, and mycotoxins) and to determine whether they require a preventive control. Additionally, your response did not address whether you need an environmental monitoring program.

Current Good Manufacturing Practice (Subpart B):

1. You did not adequately maintain equipment, utensils, and food-contact surfaces to protect against allergen cross-contact and contamination, as required by 21 CFR §§ 117.40(a)(1) and (a)(6). Specifically,

a. The conveyor belt on your chocolate enrober that carries confections from the bottomer to the enrober was frayed along the edges and had several sections missing from the edge.

b. After the candy prep table was cleaned from the production of buckeyes, the frayed edges of the conveyor belt and the metal bars underneath (that lead into the enrober) still contained ingredient residue.

c. Your chocolate enrober recycles chocolate used to coat products that pass under the chocolate curtain without any cleaning between products. During the inspection on March 15, 2021, the investigator observed the manufacture of buckeyes (peanut butter fudge balls coated and enrobed in chocolate), immediately followed by chocolate covered pretzels (which do not contain peanuts) without cleaning of the chocolate enrober. Furthermore, an ice cap (the buckeye coating resembling a large chocolate chip) is placed on the top of each buckeye before enrobing; the remaining portion of each ice cap is picked off after enrobing and placed in the small chocolate melter to feed the enrober (which may then be used for subsequent products not containing peanuts). Additionally, during the manufacture of chocolate covered gummy bears on March 23, 2021, the investigator noted pieces of pecans around and underneath the conveyor belt of the chocolate enrober; (b)(4) had ended with brown bears (chocolate covered caramels containing pecans).

d. Stock boxes used for the packing of finished product, as well as parchment paper used to line the bottom of boxes and in between each layer of candy, are reused multiple times and are not dedicated to any one specific product or allergen profile. During the inspection, on March 23, 2021, chocolate covered gummy bears were packed in a box which previously contained white chocolate almond clusters.

In your written response, you stated that you ordered a new conveyor belt for your enrobing machine; however, you did not provide evidence that you purchased the new belt or provide an estimated date of installation. You also stated that, to prevent allergen cross-contact, you will designate trays for products with specific ingredients, sanitize the enrober belt between products with different allergens, and perform a visual inspection of the machinery. However, your response did not provide details on how you plan to clean your stock boxes or enrober belt. Please note that sanitizing addresses microbial contamination and is not effective for allergen residue removal. Moreover, you did not address how recirculated chocolate that has passed over products containing allergens and is then used for products that do not contain those allergens will be handled to control allergen cross-contact. You also did not indicate any corrective actions to address the pecan build-up on the enrober machine.

You also stated that you have removed the metal bars along the candy prep table, will only put them down as needed, and will sanitize the table and bars (b)(4). However, you did not describe procedures for cleaning the table and bars, and you did not provide evidence such as photos or cleaning records to demonstrate that you have implemented these practices.

Finally, you stated that you would provide food safety training to your employees, but you did not provide information on what the training would include and when you plan to conduct the training.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please notify FDA in writing, within 15 working day of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.

Section 743 of the FDCA (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection, assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs to your facility.

If you have questions regarding the content of this letter you may contact Zada L. Giles, Compliance Officer, either via telephone at 615-366-7985, or via email at ORAHAFEAST5FirmResponses@fda.hhs.gov


Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East

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