WARNING LETTER

Chukar Cherry Company Inc. MARCS-CMS 573446 — June 27, 2019

Delivery Method:: Overnight Delivery
Product:: Food & Beverages

Recipient:: Recipient Name

Pamela Montgomery; Recipient Title

President; Chukar Cherry Company Inc.; 320 Wine Country Road
Prosser, WA 99350
United States

Issuing Office:: Division of Human and Animal Food Operations West VI; 22215 26th Avenue, Suite 210,
Bothell, WA 98021
United States

June 27, 2019

OVERNIGHT DELIVERY

SIGNATURE REQUIRED

In reply, refer to WL CMS 573446

Pamela Montgomery, President

John T. Montgomery, Chief Financial Officer

Chukar Cherry Company

320 Wine Country Road

Prosser, Washington 99350

WARNING LETTER

Dear Mrs. and Mr. Montgomery:

The U.S. Food and Drug Administration (FDA) inspected your chocolate confection production facility, located at 320 Wine Country Road, Prosser, Washington, from November 5, 2018, through November 28, 2018. The inspection was initiated in response to a consumer complaint regarding an allergic reaction and subsequent sampling conducted by FDA, which revealed elevated levels of milk protein in your Ultra Dark Chocolate Amaretto Rainier cherries. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, [Title 21, Code of Federal Regulations, Part 117 (21 CFR 117)] (CGMP & PC rule).

Although milk is not used as an ingredient in your dark chocolate covered nut and fruit products (i.e., Ultra Dark Chocolate Amaretto Rainer Cherries, Ultra Dark Chocolate Black Forest Cherries, Ultra Dark Chocolate Cocoa Pecans, Ultra Dark Vanilla Chocolate Rainier Cherries, and Ultra Dark Orange Chocolate Tart Cherries), FDA found elevated levels of milk protein in these products. Further, FDA found elevated levels of milk protein in the chocolate ingredients you use to produce your dark chocolate covered nut and fruit products. These chocolate ingredients do not include milk as an ingredient. Subsequently, you conducted voluntary recalls for the finished product lots associated with the FDA samples.

Based on FDA’s findings during the inspection we have determined that your dark chocolate covered nut and fruit products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 United States Code § 342(a)(4)] (the Act), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or 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 home page at http://www.fda.gov.

At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing the deviations found at your firm. Subsequently, we received your written responses dated December 19, 2018, and April 12, 2019 (hereinafter “responses”). Your responses are addressed below.

The following are significant violations of the CGMP & PC rule:

Preventive Controls

1. Your hazard analysis did not identify the unintentional presence of milk allergens as a hazard requiring a supply-chain applied control in the bittersweet, (b)(4) chocolate you obtain and therefore is a hazard that requires that you have a supply-chain control, as required by 21 CFR 117.130(a)(1) and 21 CFR 117.405(a)(1). Specifically, your hazard analysis, dated April 30, 2018, did not identify milk allergens as a hazard in the bittersweet, (b)(4) chocolate you purchase from a supplier for use in your dark chocolate products. The need to consider milk allergens as a hazard requiring a supply-chain-applied control was highlighted by your supplier’s allergen policy indicating the possible presence of undeclared milk allergens. Specifically, your supplier’s policy states that “dark items that do not have milk intentionally added as an ingredient may contain milk from cross contact due to processing on shared equipment.” The bittersweet, (b)(4) chocolate you received from your supplier also contained an advisory statement on the label which cautions that the product is “[m]ade on equipment also used to make milk chocolate; not suitable for individuals with milk allergies.”

We reviewed your responses and determined that this violation was not corrected. Your hazard analysis, dated April 13, 2019, does not consider food allergens (i.e., the unintentional presence of milk) as a hazard for the receiving step of your bittersweet, (b)(4) chocolate ingredients.

2. You did not conduct a reanalysis of your food safety plan when needed, as required by 21 CFR 117.170. You must conduct a reanalysis of the food safety plan as a whole or the applicable portion of the food safety plan whenever you become aware of new information about potential hazards associated with the food, as required 21 CFR 117.170(b)(2). You became aware of new information when you received a consumer complaint regarding an allergic reaction to your Ultra Dark Chocolate Amaretto Rainiers (Best By 09/2019) and subsequent test results from a third-party laboratory and FDA. Specifically, you received results from the third-party laboratory indicating the presence of milk protein in the finished product and raw ingredients on September 14, 2018, and September 19, 2018. Subsequently, you received finished product sample results from FDA indicating the presence of milk protein at levels as high as 7000 ppm in your covered nut and fruit products. You also received FDA test results of the chocolate that you obtained from your supplier indicating milk protein levels as high as 4300 ppm. However, after receiving these results, you did not conduct a reanalysis of your food safety plan dated September 12, 2018, to consider whether food allergens are a hazard requiring a supply-chain-applied control.

Although you reanalyzed your food safety plan, your hazard analysis, dated April 13, 2019, still does not consider food allergens (i.e., the unintentional presence of milk) as a hazard for the receiving step of your bittersweet, (b)(4) chocolate ingredients.

3. You did not determine and conduct appropriate supplier verification activities, as required by 21 CFR 117.415(a)(2). Specifically, you did not conduct or have conducted an onsite audit of your suppliers when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, as required by 21 CFR 117.430(b)(1)(i). You identified the food safety hazards of Salmonella and E. coli in your hazard analysis with regard to (b)(4). Further, as described above, you should have identified the unintentional presence of milk allergens as a hazard in certain of your chocolate ingredients. These are hazards that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled. The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (21 CFR 117.430(b)(1)(ii)). An annual supplier audit would, among other things, assess whether the supplier is minimizing cross contact with allergens by implementing appropriate preventive controls and Current Good Manufacturing Practices (21 CFR 117.435(b)).

Your December response provides a certificate for your pecan supplier which documents a third-party audit to ISO standards. It is not clear whether this audit addresses whether the supplier is in compliance with 21 CFR part 117 or whether the supplier is an importer required to comply with the Foreign Supplier Verification Program (FSVP) in 21 CFR 1 subpart L. Your April response provided an “AIB Certificate of Registration” stating that your chocolate supplier meets the requirements of SQF Food Safety for Manufacturing Edition 8.0, a certificate stating that your spice manufacturer conforms to the “Global Standard for Food Safety Issue,” January 2015, and a certificate documenting a third-party audit to ISO standards. It is not clear whether these audits address whether the suppliers are in compliance with any applicable FDA food safety regulations and include a review of the supplier's written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan), if any, and its implementation, for the hazard being controlled, as required by 21 CFR 117.435(b). Note that, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States. Furthermore, your responses do not indicate if you will be conducting onsite audits for the suppliers of other ingredients, such as dried cherries and berries.

4. You did not implement a preventive control, as required by 21 CFR 117.135(a). Specifically, your food safety plan dated September 12, 2018, contains the preventive control of “run order of allergenic materials” for the food safety hazard of “food allergens from other products.” However, during the inspection, our investigators did not observe this control, and their review of your records indicated you do not have a schedule in place to run a specific order of allergenic materials.

Your December response states that this preventive control has been documented. However, the “Allergen Scheduling and Cleaning Implications” section of your food safety plan states that “[a]ny chocolate product . . . may be processed in any chocolate pan depending on product demand.” It does not appear there is a clear scheduling plan in place for running non-allergenic products prior to allergenic products to reduce the chance of allergen cross-contact in your facility and reduce the need for thorough cleaning between products.

5. You are required to 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 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1). However, the food allergen controls you have in place do not ensure protection of food from allergen cross-contact, including during storage, handling and use, as required by 21 CFR 117.135(c)(2)(i). Specifically, your Allergen Preventive Controls do not include procedures regarding the use of rework to prevent cross contamination with tree nuts. On November 7, 2018, our investigators observed an employee scrape the remaining milk chocolate from the (b)(4) coater after manufacturing Honey Pecans and place the scraped chocolate into a box. The employee then emptied the box of scraped chocolate into a chocolate melter. Your employees verified that the melted rework chocolate is strained and reused for all milk chocolate products, including non-nut varieties and that this is a common practice for multiple melters in your facility.

We have reviewed your written responses and determined they are not adequate. Your responses state that a preventive control was not identified for potential cross-contact in reworked chocolate because you have been unable to identify any cross-contact when testing the melted chocolate. In your April response you provided test results for pecan and almond residue in your reworked chocolate. The number of samples and frequency of the testing was not sufficient to show that the process of straining chocolate that was in direct contact with tree nuts prevents or reduces allergen cross contact to an acceptable level.

6. You did not monitor preventive controls with adequate frequency to provide assurance that they are consistently performed, as required by 21 CFR 117.145(b). The Allergen Preventive Controls section of your food safety plan dated September 12, 2018, states that you will monitor by visual inspection the effectiveness of your “allergen change over procedures,” which should result in “no residual allergenic material from previous production/handling” on equipment and the production line.

a. On November 7, 2018, our investigators observed apparent chocolate powder and residue on the outside and inside of the air vents for pan #(b)(4) and #(b)(4). These vents are used to blow air over all varieties of chocolates including milk, tree nut, and non-milk, non-tree nut products, which could cause cross contact of milk and tree nuts in products that do not contain milk and tree nut ingredients during the (b)(4) process.

b. On November 7, 2018, our investigators observed apparent chocolate residue on the pouch machine within approximately three inches of open pouches of a non-chocolate product, Columbia River Tarts. During the inspection employees were packaging a non-chocolate containing product in close proximity to the residue.

7. You did not document the monitoring of preventive controls, as required by 21 CFR 117.145(c).

a. The Allergen Preventive Controls section of your food safety plan dated September 12, 2018, states that you will monitor by visual inspection the effectiveness of your “allergen change over procedures,” which should result in “no residual allergenic material from previous production/handling” on equipment and the production line. On November 7, 2018, our investigators observed the manufacturing of a nut-containing product (Cocoa Pecans) and the cleaning steps, which included an employee scraping the remainder of the chocolate from the pan and scrubbing the pan with hot water and a scrub brush. However, your Equipment Cleaning records (i.e., monitoring records) do not indicate that the employee conducted a visual inspection after the cleaning step and prior to the start of manufacturing a non-nut containing product, Truffle Cherries.

b. Your firm’s records for production on July 30, 2018, and on August 6, 2018, indicate your firm produced a milk-containing product, Cabernet Cherries, and subsequently manufactured a non-milk containing product, Ultra Dark Chocolate Amaretto Rainiers, on the same equipment. However, your Equipment Cleaning records do not indicate that a scrape, wash, dry, or inspection occurred between the two products.

We cannot verify the adequacy of your responses. Your December response states that you have updated cleaning procedures and retrained employees. Although your response provides documentation that you have trained your employees on the revised procedures, it is not clear what steps you will take to ensure this training was effective and to ensure these violations do not recur. In addition, your December response provides revised cleaning records that do not indicate that your cleaning procedures are being followed. Specifically, your revised cleaning records for “Choc Room Pans” do not indicate that a “scrape” was consistently performed on the pans as required by your cleaning procedure between changeovers. Your revised equipment cleaning records for the “(b)(4) Coater” do not indicate that a “vacuum” was consistently performed as required by your cleaning procedure between changeovers. Your revised equipment cleaning records for the “Pouch Machine” do not indicate that (b)(4) shutdown cleaning was consistently performed as required by your cleaning procedures.

In addition, your December response states that the food safety plan has been updated to remove reference to using detergent on the chocolate pans. It is not clear that this is an appropriate corrective action because, as stated in the Sanitation Preventive Controls section of your food safety plan, “Detergent cleaners suspend and help remove various food soils.” Your response does not indicate how you will ensure other cleaning efforts are effective at removing these proteins if you do not use detergent.

8. You did not verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens. Specifically, you did not conduct environmental monitoring, as required by 21 CFR 117.165(a)(3), and your food safety plan (21 CFR 117.126(a)). Your chocolate-covered nut and fruit products are ready-to-eat (RTE) foods exposed to the processing plant environment prior to packaging, and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Your hazard analysis identified contamination with an environmental pathogen as a hazard requiring a preventive control (sanitation preventive controls), and your food safety plan identified environmental monitoring as a verification activity for your sanitation preventive controls. However, you did not implement an environmental monitoring program.

Your responses are not adequate. Although you have collected environmental samples that were analyzed for E. coli, Salmonella, and Listeria spp., your revised environmental monitoring program only requires (b)(4) environmental monitoring. Your previous program required (b)(4) monitoring. It is not clear why you have reduced the monitoring to (b)(4). (b)(4) monitoring would not be sufficient for your manufacturing operations. The timing and frequency for collecting and testing samples must be adequate to determine whether preventive controls are effective, as required by 21 CFR 117.165(b)(3)(iv).

Current Good Manufacturing Practice

9. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b). However, on November 7, 2018, our investigators observed at least five instances when your employees returned from break and entered the chocolate room to conduct manufacturing operations without first washing their hands.

We cannot verify the adequacy of your responses. Your December response states that you have retrained employees on hand washing procedures. While your response provides documentation that you have trained your employees, it is not clear what steps you will take to ensure this training was effective and to ensure these violations do not recur.

10. You did not ensure the plumbing is of adequate size and design and adequately installed and maintained to provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing, as required by 21 CFR 117.37(b)(5). Our investigators observed (b)(4) hoses fully submerged inside the tray washing tank containing trays, water, and sanitizer. There were no backflow prevention devices in place.

Your responses are not adequate. Your December response states that you have reinstalled backflow devices and maintenance staff have been trained on requirements. However, it appears from the photographs provided that you have placed a hose bib vacuum breaker before a y-splitter. Splitters have shut-off valves and the hose bib vacuum breaker should be installed after the last shut off valve for each hose connected to the splitter so that it will not be subject to continuous pressure. Hose bib vacuum breakers are not appropriate devices if they are subject to continuous water pressure.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, (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 non-compliance 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 and 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re- inspection-related costs.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Your response should be sent to: U.S. Food and Drug Administration, 22215 26^th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Jessica L. Kocian, Compliance Officer. If you have any questions regarding this letter, please contact Compliance Officer Jessica Kocian at 425-302-0444.

Sincerely,

/S/

Miriam R. Burbach

District Director

Program Division Director