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WARNING LETTER

AH USA Group Inc. MARCS-CMS 695970 —

Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Raymond V. Tsan
Recipient Title
CEO
AH USA Group Inc.

2845 Supply Ave
Commerce, CA 90040-2705
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

February 25, 2025

Re: CMS # 695970

Dear Mr. Raymond V. Tsan,

On October 2, 2024 to October 9, 2024 the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of AH USA Group Inc., located at 2845 Supply Ave. Commerce, CA, 90040. We also conducted an inspection on August 25, 2022 to August 30, 2022. 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 food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links On 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 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 emailed response dated October 23, 2024 and we address your response below. In your email you stated your intended corrective actions, including your plan to meet and request information from your suppliers and to take a class to help you with your FSVP documentation. You also noted that two of your suppliers had provided you with certificates of analysis for the preserved starberry and rice vermicelli you import. Other than your email, no documents were submitted. We are unable to evaluate the adequacy of your response, because you have not provided any supporting FSVP documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA.

Your significant violations of the FSVP regulation are as follows:

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 foods that you import, including the following foods:

  • Dried Mushroom from (b)(4)
  • Preserved Starberry from (b)(4)
  • Rice Vermicelli from (b)(4)

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)).

In addition, we offer the following comments:

During the inspection, while you told our investigator that you did not have any FSVP records for the foods you import, you also said you started to conduct hazard analyses to identify allergens for some products but had not identified any additional hazards for the foods. You provided copies of the hazard analyses you started for the following products: durian cookies, mangosteen wafers, pineapple cookies, coconut wafers, mango wafers, mix smoke bacon biscuit sticks, mix nori seaweed biscuit sticks, mix chicky stick, mix biscuit sticks original flavor, mix hot chilli biscuit sticks, hot chilli biscuit sticks, and biscuit sticks. The documents do not list any foreign suppliers. To the extent that you intend to rely on these hazard analyses to meet your obligations under the FSVP regulation, we note that you must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards, and physical hazards (21 CFR 1.504(b)(1)). A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury (21 CFR 1.500). In addition, we note that meeting the hazard analysis requirements in 21 CFR 1.504 is not enough. The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements.

In addition, regarding the black fungus you imported from (b)(4), that was subject to recall in May 2023 due to Salmonella contamination, you said you no longer import the product, which we verified in our review of the foods you imported in the 12 months prior to our inspection. Further, for the FSVPs you are required to develop, 21 CFR 1.508(a) requires that you must promptly take appropriate corrective actions if you determine 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 and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the verification activities conducted under 21 CFR 1.506 or 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under 21 CFR 1.505(c) or (d), or any other relevant information you obtain. 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. You must document any corrective actions you take in accordance with 21 CFR 1.508(a).

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 your products 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: Jeff Gard, Compliance Officer, Division of West Coast Imports, 19701 Fairchild, Irvine, CA 92612. If you have any questions regarding this letter, you may contact Jeff Gard via email at jeff.gard@fda.hhs.gov. Please reference CMS # 695970 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

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