Union Trade Inc.

WARNING LETTER Union Trade Inc. MARCS-CMS 729071 — 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 Xu Chen Recipient Title Chief Executive Officer Union Trade Inc. 333 City Blvd W Ste 1210 Orange , CA 92868-5908 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States August 27, 2026 WARNING LETTER Re: CMS # 729071 Dear Mr. Chen: On April 06, 2026 and April 07, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Union Trade Inc. located at 333 City Blvd W Ste 1210, Orange CA 92868-5908. 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 United States 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-supplierverification-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 from 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. We acknowledge receipt of your response, dated April 9, 2026, in which you described intended corrective actions for all six observations noted on the FDA 483a. You stated that you will revise the FSVP program, update supplier evaluation forms and risk classification matrix, complete hazard analyses and evaluations within 60 days, and have an FSVP for all products within 90 days. You also committed to developing hazard analyses for crisp radish and dried mushrooms within 5 business days, completing hazard analyses for all products within 2 months, revising FSVP written procedures for verification activities within 10 business days, and pausing importation of any products that do not have a hazard analysis. You promised to conduct a supplier evaluation for (b)(4) within 5 business days, and to document corrective actions for the dried mushrooms within 3 business days. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA. 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 you import from the foreign suppliers indicated in the attached list, including each of the following foods: crisp radish imported from (b)(4) located in (b)(4) . peanut, in shell imported from (b)(4) , located in (b)(4) (b)(4) (subtropical and tropical fruit) from (b)(4) , located in (b)(4) 2. You did not document that you took appropriate corrective actions after you determined that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations or produced food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the FD&C Act, as required by 21 CFR 1.508(a). Specifically, dried mushrooms manufactured by (b)(4) , were found to contain undeclared sulfites, which resulted in two Class 2 recalls, but you did not provide any documentation to show that you took corrective actions as a result of this finding. We note that your FSVP Program Overview states that if a supplier or product is found to present a food safety concern, appropriate corrective actions will be taken and all actions will be documented. Under 21 CFR 1.508(a), the appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. Your response indicates that for your dried mushrooms from (b)(4) you would document your corrective actions within three business days. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. 3. You did not conduct a 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 this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of the hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During the inspection, you provided FSVP documents for your dried mushrooms imported from (b)(4) , that included a supplier evaluation, supplier compliance statement, HACCP System Certificate, (b)(4) Certificate and (b)(4) analytical report. Although your written response indicates that you will develop a hazard analysis for dried mushrooms within five business days, you did not provide documentation during the inspection or in your response that you have conducted a hazard analysis or reviewed and assessed a hazard analysis conducted by another entity, as required by 21 CFR 1.504(d). 4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506(e) for the products you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for your dried mushrooms imported from (b)(4) , located in (b)(4) . During the inspection, you provided FSVP documents that included a supplier evaluation, supplier compliance statement, a HACCP System Certificate, (b)(4) Certification and (b)(4) heavy metal analytical report, as well as an FSVP Program Overview that includes a Risk Classification and Verification Matrix, that are listed as documentation of your approval of the supplier. To the extent these records that could be used to satisfy the requirements to perform verification activities, you did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). Furthermore, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b). While your written response dated April 9, 2026, indicated that you will revise your FSVP written procedures for verification activities within 10 business days and develop verification activities for dried mushrooms from (b)(4) within five business days, you did provide any supporting documentation demonstrating your corrective actions. 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)). Additionally, we offer the following comment: Your supplier evaluation for dried mushrooms from (b)(4) , dated June 5, 2025, included records that include a HACCP System Certificate and (b)(4) Certification. However, these documents alone do not demonstrate that you have approved your foreign suppliers on the basis of an evaluation of your foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a), for the products you import. In approving your foreign suppliers and determining the appropriate supplier verification activities, you must consider the hazard analysis of the food conducted per 21 CFR 1.504, including the nature of the hazard requiring a control, as required by 21 CFR 1.505(a)(1)(i). You must also consider the foreign supplier’s procedures, processes, and practices related to the safety of the food, as required by 1.505(a)(1)(iii)(A), and the applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations, as required by 21 CFR 1.505(a)(1)(iii)(B). In your written response dated April 9, 2026, you stated that you had already decided not to purchase any dried mushrooms from (b)(4) upon being notified of the two Class 2 recalls for undeclared sulfites. We note that if you resume importing food from this foreign supplier, under 21 CFR 1.505(c), you must promptly reevaluate the concerns associated with the factors under 21 CFR 1.505(a)(1), regarding the foreign supplier's performance, including applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, recalls, or other FDA compliance action related to food safety, per 21 CFR 1.505(a)(ii)(B). You must also document any investigations, corrective actions, and changes to your FSVP that you undertake (21 CFR 1.508(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 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: Celena Ngo, 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, or wish to send your response electronically, you may contact Celena Ngo via email at celena.ngo@fda.hhs.gov. Please reference CMS # 729071 on any documents or records you provide to us and on 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: 09/22/2026 Regulated Product(s) Food & Beverages