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WARNING LETTER

Wisetrade Corporation MARCS-CMS 657707 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Ms. Elena Kong
Recipient Title
Director
Wisetrade Corporation

15615 Alton Pkwy Ste 450
Irvine, CA 92618-3308
United States

Issuing Office:
Division of West Coast Imports

United States


WARNING LETTER

June 30, 2023

Re: CMS 657707

Dear Ms. Kong:

On February 15, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Wisetrade Corporation located at 15615 Alton Pkwy Ste 450 Irvine, CA 92618-3308. 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.

Our inspection was initiated in response to the recent recall event associated with enoki mushroom products imported by you from one of your foreign suppliers. Specifically, you were notified by the California Department of Public Health that retail samples of fresh enoki mushroom products, imported from your foreign supplier, (b)(4), and shipped to you by (b)(4), both located in the Republic of Korea, tested positive for Listeria monocytogenes. In response to these analytical findings, you conducted a voluntary recall of the imported fresh enoki mushroom products on March 23, 2022.

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 following foods you import: enoki mushrooms imported from (b)(4) located in the Republic of Korea; oyster mushrooms imported from (b)(4) located in the Republic of Korea; and enoki mushrooms, shitake mushrooms, and oyster mushrooms imported from (b)(4) located in the Republic of Korea. 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 FDA 483a issued on February 15, 2023.

Your significant violations are as follows:

1. If you are 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. During our inspection, you told the investigator that, except for oyster mushrooms imported from (b)(4) located in the Republic of Korea, you did not have written assurances from your foreign suppliers for any of your foods, including enoki mushrooms imported from (b)(4) located in the Republic of Korea, oyster mushrooms imported from (b)(4) located in the Republic of Korea, and enoki mushrooms, shitake mushrooms, and oyster mushrooms imported from (b)(4) located in the Republic of Korea.

2. You did not document that you took appropriate corrective actions after you were notified about an adulteration issue with your foreign supplier of food you import, in accordance with 21 CFR 1.512(b)(4). Specifically, on March 23, 2022, you voluntarily recalled enoki mushrooms you imported from (b)(4) on or about January 26, 2022, after the California Department of Public Health notified you that they analyzed retail samples of your enoki mushroom product and detected Listeria monocytogenes. We also note that, on February 16, 2022, (b)(4) was placed on FDA’s Import Alert # 99-23, “Detention Without Physical Examination of Produce Due to Contamination with Human Pathogens,” after FDA analyzed a sample of enoki mushrooms supplied by (b)(4), detected Listeria monocytogenes, and determined the enoki mushrooms were adulterated. (b)(4) was subsequently placed on Import Alert # 25-21, “Detention Without Physical Examination of Enoki Mushrooms from the Republic of Korea and China due to Listeria Monocytogenes.”

Although you stated during the inspection that you would no longer import enoki mushrooms from any foreign suppliers, you did not document this corrective action, or any other corrective actions taken by you in response to this Listeria monocytogenes contamination.

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 from the identified foreign suppliers on Detention Without Physical Examination (DWPE) when you import the products. 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 15 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: Nabeela J. Chaudhry, Compliance Officer, Division of West Coast Imports, 1 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 Nabeela Chaudhry via email at nabeela.chaudhry@fda.hhs.gov. Please reference CMS #657707 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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