Premier Produce LLC - 553107 - 10/19/2018

October 19, 2018

WARNING LETTER 553107

UNITED PARCEL SERVICE

Delivery Signature Requested

Marvin T. Harned, Owner

Premier Produce LLC dba Bud’s Produce

2521 Ring Road

Elizabethtown, Kentucky 42701-9107

Dear Mr. Harned:

The U.S. Food and Drug Administration (FDA) inspected your fresh-cut produce production facility, Premier Produce LLC dba Bud’s Produce, located at 2521 Ring Road, Elizabethtown, Kentucky, from March 26- 29, 2018. The inspection, which focused on your ready-to-eat (RTE) fresh-cut produce products, 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).

Based on FDA’s findings during the inspection, we determined your fresh-cut produce 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 USC 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 firm’s response dated April 10, 2018. Your response is addressed below.

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

1. Your firm did not maintain a written hazard analysis for your RTE fresh-cut produce products, as required by 21 CFR 117.130(a)(2). Specifically, on March 28, 2018, your food safety manager reported your firm did not have a written hazard analysis for your fresh-cut produce.

Your response dated April 10, 2018, indicated that a hazard analysis was conducted based on the (b) (4) HACCP model, but this hazard analysis was not documented in writing. Further, you indicated in your response you are conducting and documenting a hazard analysis for each type of commodity handled by your firm. However, you did not provide copies of these written hazard analyses to FDA or any timeframe for complying with 21 CFR 117.130(a)(2).

2. Your firm did not verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a likely pathogen hazard. Specifically, you did not conduct environmental monitoring, as required by 21 CFR 117.165(a)(3). Environmental pathogens are a hazard requiring a preventive control for fresh-cut produce that will not be further processed or cooked by the customer. Your fresh cut RTE produce is exposed to the processing plant environment prior to packaging and the packaged RTE produce does not receive a treatment or otherwise include a control measure. Further, such products have been associated with recalls and outbreaks due to environmental pathogens such as Listeria monocytogenes. Your hazard analysis should have identified contamination with an environmental pathogen as a hazard requiring a preventive control (sanitation preventive controls). Verification of sanitation controls must include environmental monitoring procedures for pathogens or an appropriate indicator organism, in accordance with 21 CFR 117.165(b)(3).

Your response dated April 10, 2018, indicates you will create and implement an environmental testing program. We cannot evaluate your response because you did not provide details of your proposed plan and/or a copy of your plan; and you did not provide documentation of when and how it will be implemented.

3. Your firm did not establish and implement a written supply-chain program, as required by 21 CFR 117.405(a)(1). Specifically, your firm does not have a supply-chain program to control the hazard of pathogens for produce that will be used to make RTE fresh-cut produce products, including using approved suppliers and conducting supplier verification activities in accordance with 21 CFR 117.410.

Your response dated April 10, 2018, indicates that you are currently taking steps to come into compliance with these requirements but does not provide details of those steps. The adequacies of your supply-chain program will be verified during the next FDA inspection.

4. All plant equipment and utensils were not so designed and of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1). Specifically, on March 26, 2018, FDA observed that the cutting board used in the fresh-cut produce processing room had deep scoring allowing for areas that cannot be adequately cleaned and sanitized. This board was observed being used to cut fresh fruits and vegetables that were intended for raw consumption (RTE).

Your response indicates new cutting boards are being installed. Your response did not provide documentation demonstrating implementation of your corrective actions, including photographs, invoices, or other documentation.

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 incompliance 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 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 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 written response should be sent to Zada L. Giles, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have questions regarding the content of this letter, please contact Ms. Giles at (615) 366-7985 or Zada.Giles@fda.hhs.gov.

Sincerely,

/S/

Steven B. Barber Director, Division V

Office of Human and Animal Foods Operations-East