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Country Fresh Inc. MARCS-CMS 591206 —

Delivery Method:
United Parcel Service
Food & Beverages

Recipient Name
Mr. William Anderson
Recipient Title
Country Fresh Inc.

3200 Research Forest Drive, Suite A5
Spring, TX 77381
United States

Issuing Office:
Office of Human and Animal Food Operations West Division 3

United States

CMS: 591206


December 12, 2019


Dear Mr. Anderson:

The United States Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE) fresh cut produce manufacturing facility, located at 920 Avenue R, Suite 100, Grand Prairie, TX 75050, from July 9, 2019, through July 17, 2019. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP and PC Rule), Title 21, Code of Federal Regulations (CFR), Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples from various areas in your facility, including areas that are near food processing operations. FDA laboratory analyses of the environmental samples (i.e., swabs) found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that your RTE products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that 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.

Additionally, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provision of the CGMP & PC rule (located in subparts A, B, 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 www.fda.gov.

FDA’s inspection resulted in issuance of an FDA-483, Inspectional Observations, listing deviations found during our inspection. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We received your firm’s email response to the positive L. monocytogenes sample findings sent on July 29, 2019, your response to the FDA Form-483 (FDA-483) sent on August 7, 2019, and your response to the Whole Genome Sequencing (WGS)(of the pathogen sent on August 20, 2019. Your responses included written summaries of corrective actions, sanitation and cleaning procedures, environmental swab results in response to the L. monocytogenes findings, a supplier approval review, training documentation, and other supporting documentation. However, you did not provide supporting documentation of all of your corrective actions. We will verify the adequacy of your corrective actions during our next inspection.

Your significant violations are as follows:

1. 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 of the Act 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).

a. You did not identify and implement a preventive control adequate to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes from contaminating RTE produce in your facility, as required by 21 CFR 117.135(a)(1) and (c)(3). The failure to have an adequate preventive control that significantly minimizes or prevents the environmental hazard of L. monocytogenes is reflected in Seven (7) environmental swabs (sample # 1113254) collected by FDA during our most recent inspection at your Country Fresh location in Grand Prairie, TX that were positive for L. monocytogenes. These samples were collected from the rubber base of the cutting table located on the NE side, the floor drain located on the SE side of the feeding table, the right leg of the pallet jack in the cold storage area, the East side of the cracked floor between the Fruit Room (b)(4) and cold storage, the middle of the cracked floor between the Fruit Room (b)(4) and cold storage, the blue squeegee in Fruit Room (b)(4), and the left back side of the orange cull waste basket in Fruit Room (b)(4). Furthermore, a retail product sample of watermelon spears (sample # 1108315) collected at Wal-Mart on May 9, 2019, by FDA tested positive for L. monocytogenes. The watermelon spears were manufactured at your Country Fresh location in Grand Prairie, TX. WGS of the sample revealed that it matched an environmental sample collected by the State of Texas in 2013 at your Country Fresh location in Houston, TX and historical clinical isolates. You stated that the two Country Fresh locations (Grand Prairie and Houston) shared product, equipment, and suppliers.

These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes from contaminating RTE fresh cut produce in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

b. You did not implement your preventive control to prevent cross-contamination during washing. Your firm identified holding fruit in (b)(4) for (b)(4) to (b)(4) as a critical limit to control for pathogens such as Listeria monocytogenes and Salmonella. In addition, you stated that employees are required to (b)(4). On July 9, 2019, the FDA investigator observed an employee on the cantaloupe line not allowing the fruit (b)(4) for (b)(4) as required in your food safety plan. In addition, you do not have monitoring records to document employees are allowing fruit (b)(4) for (b)(4) to (b)(4).

2. You did not validate that your preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system, to comply with 21 CFR 117.160. Specifically, you did not properly validate your preventive control for the use of (b)(4) to prevent cross-contamination. The study presented by your firm is titled “EPA Food Contact Sanitizer Test for Previously Cleaned Food Contact Surfaces (AOAC Germicidal and Detergent Sanitizing Action of Disinfectant) against Salmonella choleraesuis and Listeria monocytogenes.” That study pertains to food contact surfaces and was not designed to validate, nor is it adequate to validate, the antimicrobial efficacy of peracetic acid against pathogen cross-contamination during the produce washing process.

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 that your facility operates in compliance with the Act 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 FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, [21 USC 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 USC 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 receipt of this letter as to the specific steps you have taken to correct the stated violation, 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 revised procedures, photographs, results of testes you have conducted, and 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, stated the reason for the delay and the timeframe within which the corrections will be implemented.

Your written response should be sent to Casey L. Hamblin, Recall Coordinator/Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions regarding the content of this letter, please contact Mrs. Hamblin at 214-253-5222 or Casey.Hamblin@fda.hhs.gov.


Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director

Cc: Mr. Gregory L. Werbaneth
Plant Manager
920 Avenue R
Suite 100
Grand Prairie, TX 75050

Texas Department of State and Health Services
Lori Woznicki, M.P.H
Food and Drug Inspections Branch Manager
1100 West 49th Street
Austin, TX 78756

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