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June 9, 2022

WARNING LETTER

Re: CMS # 629870

Dear Mr. Chang:

On March 7 through 15, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Winfull Corporation, 15320 Park Row, Houston, TX 77084-2887. We also conducted an inspection that concluded April 24, 2020. 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.

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 have not received your response to the Form FDA 483a issued on March 15, 2022.

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, maintain, and follow an FSVP for any of the foods that you import, including:

• AA Grade Grass Jelly Drink Beverage Base from (b)(4), located in (b)(4)
• Passion Fruit with Pulp Syrup from (b)(4), located in (b)(4)
• Kidney Beans from (b)(4), located in (b)(4)

2. For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), and with respect to the microbiological hazards associated with these food products, you must verify and document that they were produced in accordance with 21 CFR part 113. Specifically, you did not verify and document that the canned food products you import, including but not limited to AA Grade Grass Jelly Drink Beverage Base and Kidney Beans, were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).

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 have the following comments:

You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection, as required by 21 CFR 1.509(a). As the owner or consignee of food that is being offered for import into the United States, you are the importer (see 21 CFR 1.500). The entries reviewed during the inspection did not include a valid unique facility identifier. Specifically, you did not provide a DUNS number for shipments of AA Grade Grass Jelly Drink Beverage Base you imported in entry 349-0103009-7 and Kidney Beans you imported in entry 349-2036796-7. You provided a DUNS number corresponding to your firm’s previous address for the Passion Fruit with Pulp Syrup you imported in entry 349-1034883-7. It is your responsibility to ensure that the required information under 21 CFR 1.509(a) is provided at the time of entry.

In addition, based on the information available to the agency, it appears you may meet the definition of a very small importer, as defined in 21 CFR 1.500. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 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 (21 CFR 1.512(b)(3)(i)).

You may find information on documenting your eligibility as a very small importer and the other requirements under 21 CFR 1.512 in the “Draft Guidance for Industry Foreign Supplier Verification Programs for Imports of Food for Human and Animals at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals.

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: Lisa Puttonen, Compliance Officer, Division of Southwest Imports, One Main Place, 1201 Main St, Suite 7200, Dallas, Texas 75202. If you have any questions regarding this letter, you may contact Lisa Puttonen via email at lisa.puttonen@fda.hhs.gov. Please reference CMS # 629870 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
Director, Southwest Imports