Andrighetto Produce Inc dba Shasta Produce Inc

WARNING LETTER Andrighetto Produce Inc dba Shasta Produce Inc MARCS-CMS 725332 — August 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name David A. Andrighetto Recipient Title Chief Executive Officer Andrighetto Produce Inc dba Shasta Produce Inc 155 Terminal Ct Ste 24 South San Francisco , CA 94080-6535 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States August 27, 2026 WARNING LETTER Re: CMS 725332 Dear Mr. Andrighetto: On February 5, 6, and 10, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Andrighetto Produce Inc dba Shasta Produce Inc located at 155 Terminal Ct Ste 24, South San Francisco, CA 94080-6535. This inspection was 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. 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. We acknowledge receipt of your response dated February 27, 2026, and we address your response below. 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 any of the foods you import, except for the following foods: eggplant, bitter melon, sweet pepper, summer squash, and tomato imported from (b)(4) , located in (b)(4) . During our inspection you provided product invoices for (b)(4) bitter melon, fresh (b)(4) beans (green beans) and fresh (b)(4) summer squash from various foreign suppliers. However, it is not clear how these documents would apply to your FSVP program, and you did not explain how they would apply to your FSVP program. You import fresh produce that may be considered “covered produce” as defined in 21 CFR 112.3. If after review of the fresh produce that you import you determine that you are an importer of covered produce, you must have an FSVP that demonstrates 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). 2. You did not meet the requirement to conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504(a). Although you may meet your requirement to determine whether there are any hazards requiring a control by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). In your written response dated February 27, 2026, you provided HACCP plans from your foreign suppliers (b)(4) and (b)(4) , which included hazard analyses. We understand the hazard analyses to be for the food you import from these foreign suppliers, including your eggplant, bitter melon, sweet pepper, summer squash, and tomato that you import from (b)(4) . However, you did not document that you reviewed and assessed the hazard analyses from your foreign suppliers, or that the hazard analyses were conducted by a qualified individual as required by 21 CFR 1.504(d). 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 you import into the United States 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)). We also offer the following comments: Regarding the records you provided in your February 27, 2026, response for foods from foreign suppliers, (b)(4) and (b)(4) , your “Food safety verification assessment” record provided for each of these suppliers indicated you have a “3rd party certification” and that these suppliers are approved temporarily, pending “outcome” or “receipt and review” of a “3rd party audit report.” You also provided (b)(4) certificates for (b)(4) and a (b)(4) Certificate for (b)(4) . With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor and considers applicable FDA food safety regulations (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). You must also promptly review and assess any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)). Additionally, you provided lists of “approved temp” and “inactive” foreign suppliers for the food you import, including food(s) imported from (b)(4) . While you provided your lists of foreign suppliers, you did not provide any detailed explanation of your procedures used to evaluate your suppliers. We remind you that you are required to establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505 (or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to adequate verification activities before importing the food), and document your use of these procedures, as required by 21 CFR 1.506(a)(1). 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 working 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: Sandra K. Wangen, Compliance Officer, Division of West Coast Imports, 934 Broadway, Suite 101, Tacoma, WA 98402; or via email to wcid@fda.hhs.gov, Attention: Sandra K. Wangen, Compliance Officer. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 725332 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: 09/29/2026 Regulated Product(s) Food & Beverages