Tijuana’s Produce Inc.

WARNING LETTER Tijuana’s Produce Inc. MARCS-CMS 661522 — August 24, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Argelia R. Castrellon Recipient Title President Tijuana’s Produce Inc. 3301 Fruitland Ave Vernon , CA 90058-3713 United States Issuing Office: Division of West Coast Imports United States WARNING LETTER August 24, 2023 RE: CMS # 661522 Dear Mrs. Castrellon: On April 27, 2023 through May 2, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Tijuana’s Produce Inc., located at 3301 Fruitland Ave, Vernon, CA 90058-3713. We also conducted inspections on November 1, 2018; February 3, 2021 to March 12, 2021; and August 24, 2021 to September 24, 2021. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier- verification-programs-fsvp-importers-food-humans-and-animals. During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers indicated in the attached list. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. Your significant violations of the FSVP regulation are as follows: 1. You did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods from the foreign suppliers indicated in the attached list, including each of the following foods: • Fresh Seedless Watermelon imported from (b)(4) , located in (b)(4) • Fresh Cucumbers imported from (b)(4) , located in (b)(4) During the most recent inspection, you stated it would take approximately four months for you to develop FSVPs for the foods and suppliers for which you do not have an FSVP. As of the date of this letter, we have not received any information regarding your FSVPs for these food products. The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L. This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)). Additionally, we offer the following comments: • You import fresh produce, which is “covered produce” as defined in 21 CFR 112.3. Your FSVP must demonstrate that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112). • During the most recent inspection, you stated that you rely on a third party food safety audit as part of your foreign supplier verification activities for your Fresh Persian Limes imported by (b)(4) , located in (b)(4) . However, you were unable to explain how the third party audit considered the Produce Safety Rule. After discussion with the FDA Investigator, you stated that you now understand the need to evaluate and verify that your foreign suppliers are following the Produce Safety Rule. In your response dated May 17, 2023, you state that, where your foreign suppliers’ use of their “3rd party inspection falls short,” you will use a “qualified representative entity to inspect onsite and determine that the foreign supplier is conducting as per condition of the Produce Safety Rule standards.” Note that, for food that is subject to one or more FDA food safety regulations, an onsite audit must consider such regulations and include a review of the supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled (or, 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 determined to be equivalent to that of the United States) (21 CFR 1.506(e)(1)(i)(B)). You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. Please send your reply to Food and Drug Administration, Attention: William Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS # 661522 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us. Sincerely, /S/ Dr. Kathleen Turner Program Division Director Division of West Coast Imports Content current as of: 10/10/2023 Regulated Product(s) Food & Beverages