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WARNING LETTER

December 7, 2022

Re: CMS # 638293

Dear Mr. Sui-Rong Tan:

On June 21 and 22, 2022, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of AMO and Wing Inc. dba T and H Trading Co. located at 968 89th Ave, Oakland, CA 94621-1208. We also conducted an inspection on May 18, 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 Code of Federal Regulations (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 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 to the Form FDA 483a, FSVP Observations dated July 1, 2022, in which you stated that you are “qualified to declare as a small importer” and provided documents that support your “import sales” were less than $1 million per year between 2019 and 2021. We understand your response to mean that you may meet the definition of a very small importer (VSI) under 21 CFR 1.500, based on your statements to our investigator during the inspection that you planned to document such. In your response you also requested for an extension of thirty (30) days to obtain letters of assurance from your foreign suppliers. As of the date of this letter, we have not received your written assurances from your foreign suppliers.

With respect to your documentation of import sales, we note that per 21 CFR 1.500, very small importer means: With respect to the importation of human food, an importer (including any subsidiaries and affiliates) averaging less than $1 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee).

Your significant violations of the FSVP regulation are as follows:

As a very small importer, for each food you import, you must obtain written assurance, in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign 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 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act. Specifically, you did not provide written assurances from your foreign suppliers for any of the foods you import, including dried noodle and dried bean curd from (b)(4); and 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)).

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 fifteen (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: Debbie Giang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Debbie Giang via email at Debbie.Giang@fda.hhs.gov. Please reference CMS # 638293 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