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  5. Kuiyi International Inc. - 614706 - 06/29/2021
  1. Warning Letters

WARNING LETTER

Kuiyi International Inc. MARCS-CMS 614706 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Kui Zhang
Recipient Title
Chief Executive Officer
Kuiyi International Inc.

2311 E Locust Ct
Ontario, CA 91761-7614
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

June 29, 2021

Re: CMS 614706

Dear Mr. Kui Zhang:

From February 11 to March 5, 2021, the Food and Drug Administration (FDA) initated an inspection in person and conducted the remainder of the Foreign Supplier Verification Program (FSVP) inspection remotely for Kuiyi International Inc. located at 2311 E Locust Ct Ontario, CA 91761. We also conducted an inspection on April 24, 2019. 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 at https://www.fda.gov/food/foodsafety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-foodhumans-and-animals.

During our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for food products that you import, including your Baked Rice Chips imported from (b)(4), located in (b)(4); Unif Kumquat Green Tea and Unif Sneaking Around Tea imported from (b)(4), located in (b)(4); and (b)(4) Potato Chips imported from (b)(4), located in (b)(4). You did not have FSVPs for these or any of the products you import. Because of these significant violations, you are not in compliance with Section 805 of the FD&C Act.

This inspection was initiated as a follow up to a consumer complaint that resulted in injury due to anaphylactic reaction to undeclared milk allergens in one of these products. Import records and distribution records for the most recent shipment confirmed that (b)(4) Potato Chips is supplied by (b)(4), located in (b)(4) and was imported by your firm Kuiyi International Inc. Undeclared allergens are a serious adverse health consequences or death to humans or animals (SAHCODHA) hazard.

At the conclusion of the initial FSVP inspection on April 24, 2019 and the follow-up inspection on March 5, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. As of the date of this letter, we have not received your response to either Form FDA 483a.

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)1. Specifically, you did not develop, maintain, and follow an FSVP for any of the products you import, including each of the following food products:

  • Baked Rice Chips imported from (b)(4), located in (b)(4)
  • Unif Kumquat Green Tea imported from (b)(4), located in (b)(4)
  • Unif Sneaking Around Tea imported from (b)(4), located in (b)(4)
  • (b)(4) Potato Chips,(b)(4) imported from (b)(4), located in (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. Failure to adequately address this matter may result in 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 products you import for which you appear to be in violation of section 805. We may place the foods you import 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 repond 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.

Additionally, we offer the following comment:

During the most recent inspection, you noted that you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. 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 chose 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 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 and 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)).

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. If you have any questions regarding this letter, you may contact Nabeela Chaudhry via email at nabeela.chaudhry@fda.hhs.gov. Please reference CMS #614706 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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