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- Food & Beverages
Recipient NameDawn C. Young
- Tailor Cut Produce Inc.
832 Ridgewood Avenue
North Brunswick, NJ 08902-2200
- Issuing Office:
- Division of Human and Animal Food Operations East II
July 8, 2020
Dear Ms. Young:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) fresh-cut produce processing facility located at 832 Ridgewood Avenue, North Brunswick, NJ, from De-cember 10, 2019 through February 7, 2020. The inspection was initiated as part of an ongoing Salmonella Javiana multi-state outbreak investigation. According to the Centers for Disease Control and Prevention (CDC), 165 people in fourteen states were infected with the outbreak strain of Salmonella Javiana. On December 6, 2019, your firm recalled Fruit Luau, cut honeydew, cut cantaloupe, and cut pineapple in 2, 1-gallon tubs per case, manufactured between November 15, 2019 and December 1, 2019 because they had the potential to be contaminated with Salmonella. CDC and FDA have determined, based on the epidemiologic and traceback evidence, that the RTE Fruit Luau product (a fresh-cut produce mix consisting of fresh-cut cantaloupe, honeydew, pineapple, and red grapes) processed at your facility was the source of this multi-state Salmonella Javiana outbreak.
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 Part 117). At the conclusion of the inspection, the FDA investigators issued your facility an FDA Form 483, “Inspectional Observations”. Based on FDA’s inspectional findings, we determined the RTE fresh-cut produce manufactured in your facility is 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 it was prepared, packed, or held under insanitary conditions whereby it 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 home page at http://www.fda.gov.
We received your written response on February 21, 2020, which describes your completed and planned corrective actions. After reviewing the inspectional findings and responses you provided, 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 (Subpart C):
1. Your hazard analysis did not identify and evaluate a known or reasonably foreseeable haz-ard to determine whether it requires a preventive control, as required by 21 CFR 117.130(a)(1). Specifically, your hazard analysis did not identify and evaluate environmen-tal pathogens to determine whether they are a hazard requiring a preventive control (e.g., sanitation controls). Your RTE Fruit Luau products are exposed to the environment at the processing, mixing, weighing, and packaging steps, and the packaged food does not re-ceive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.
2. 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, as required by 21 CFR 117.135(a)(1). As evidenced by the following, you did not appropriately identify supply-chain controls, or adequately implement sanitation controls.
a. You did not identify and implement supply-chain controls. Your “Raw Material Hazard Analysis for Fruit Luau” (Reviewed 8/15/16) indicates that “biological hazards” are known hazards with “low likelihood” and “low severity”; the rationale for this determination is not provided. Pathogens such as Salmonella, Listeria monocytogenes, and pathogenic E. coli are known or reasonably foreseeable hazards in raw agricultural commodities such as fruits and vegetables and have resulted in foodborne illnesses, some of which are severe. The Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule in 21 CFR part 112 was established to minimize such contamination through on-farm controls.
Your revised hazard analysis dated February 9, 2020, identifies a process control for washing whole fresh fruit (including cantaloupe, pineapple, honeydew and red grapes) in a (b)(4) solution at the wash step prior to cutting as the preventive control for the hazard of pathogens such as Salmonella spp. and Listeria monocytogenes. (b)(4) solution does not significantly minimize or prevent pathogens that may require a preventive control at other stages of production, such as pathogens on incoming produce or in the production environment. You do not have any controls in place to ensure that the incoming whole fresh fruit from your suppliers has minimal risk of contamination with pathogens at receipt, and you have not provided documentation showing you have implemented a written supply chain program that includes supplier approval and supplier verification activities, such as onsite audits.
b. You did not implement the cleaning procedures in your “Tailor Cut Produce Cleaning and Sanitizing Food Contact Surfaces Policy,” which is a sanitation preventive control. The policy indicates that you will use an approved cleaning solution/detergent to remove all visible contamination from equipment parts and all other food contact surfaces, (b)(4), and then sanitize using a (b)(4) solution. However, our Investigators observed that you did not clean your processing equipment for RTE fruit mixes with an approved cleaning solution/detergent before you applied the (b)(4) solution. Further, your management stated that the food contact surfaces were sanitized using the (b)(4) solution without first being cleaned.
Additionally, you do not monitor your sanitation practices regarding cleaning and sanitizing of food contact surfaces to ensure they are not a source of contamination. Specifically, you did not implement your “(b)(4)”, which requires “(b)(4) on food contact surfaces”. Your management (b)(4). Your management also stated that currently there is no other monitoring being conducted.
Your response includes a standard operating procedure (SOP) for cleaning and sanitizing food contact surfaces, revised January 29, 2020. This SOP includes procedures for washing equipment and utensils before sanitizing. However, your response does not include any documentation or completed records to show that this has been implemented (e.g., monitoring records). We will verify the adequacy of the corrective actions and implementation during the next inspection.
c. You did not implement your “Hand Washing SOP,” which you use as a sanitation preventive control. The SOP states that employees are to wash and sanitize hands and put on gloves, and it lists when employees must do so, including before starting work and after breaks. The procedure also describes monitoring, corrective actions, and verification activities. During the inspection, management stated that the hand-washing sinks in the main processing room and in the washroom were not used, and that employees use hand sanitizer and wear disposable gloves during production. Our Investigators observed employees touching non-food contact surfaces upon entering the processing areas (e.g., doors, door handles and plastic curtain strips) without subsequently washing their hands, which could result in cross-contamination of food and food contact surfaces from insanitary objects. In addition, the hand-washing sinks in the processing rooms were inaccessible during production.
Your hand-washing SOP, revised January 3, 2020, includes procedures for washing hands with soap. However, your response does not include any documentation or completed records to show that this has been implemented (e.g., monitoring records). We will verify the adequacy of the corrective actions and implementation during the next inspection.
3. You did not establish and implement adequate written procedures for environmental monitoring to verify your sanitation controls as specified by 21 CFR 117.165(b)(3). Your fresh-cut RTE fruit mix is exposed to the processing plant environment at the processing, mixing, weighing and packaging steps, and the packaged RTE fruit mix does not receive a treatment or otherwise include a control measure that would significantly minimize an environmental pathogen. Your “Cleaning and Sanitizing Food Contact Surfaces Policy” indicates that you will perform daily swab testing for the presence of ATP on food contact surfaces following the sanitization process. However, your policy does not include written procedures for environmental monitoring that identify the test microorganism(s), the number and location of sampling sites, the timing and frequency for collecting and testing samples, the test(s) conducted including the analytical method(s) used, and the laboratory conducting the testing. In addition, 21 CFR 117.165(a)(3) specifies environmental monitoring be for an environmental pathogen, or for an appropriate indicator organism.
Food Facility Registration:
The FDA has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that as of the date of this letter, your facility is not currently registered.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately.
Registration may be submitted electronically at http://www.fda.gov/furls. We strongly encourage the use of electronic format as it is more efficient and provides for immediate submission of the registration information and immediate issuance of the registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form can be downloaded at: http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm or can be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 240-247-8804, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
Food Facility Registration (HFS-681)
College Park, Maryland 20740
When completed, the form may be faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number via email to the facility address provided.
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, 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 revised procedures, photographs, results of tests 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, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be sent to Compliance Officer Jessica Weber at United States Food & Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at (410) 779-5407, or by email at firstname.lastname@example.org.
John F. Sheehan
Acting Program Division Director and District Director
Human & Animal Food Division II East
Baltimore District Office