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  5. Juquilita Mexican Imports LLC - 678902 - 03/25/2024
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WARNING LETTER

Juquilita Mexican Imports LLC MARCS-CMS 678902 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Alfonso Jimenez Ruiz
Recipient Title
Owner/Governor
Juquilita Mexican Imports LLC

507 Queen Avenue NE
Renton, WA 98056-7405
United States

Issuing Office:
Division of West Coast Imports

United States


March 25, 2024

WARNING LETTER

Re: CMS # 678902

Dear Mr. Alfonso Jimenez Ruiz:

On February 2, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Juquilita Mexican Imports LLC, 507 Queen Avenue NE, Renton, WA 98056-7405. We also conducted an inspection on December 14, 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 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, your firm is 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 2, 2024.

Your significant violation of the FSVP regulation is 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 of the foods you import, including each of the following foods:

  • Pasteurized String Cheese, imported from (b)(4), located in (b)(4)
  • Black Mole, imported from (b)(4), located in (b)(4)
  • Pumpkin Seeds, imported from (b)(4), located in (b)(4)

During our inspection, you indicated you choose to comply with the requirements for very small importers and may meet the definition of a “very small importer.” If you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of a very small importer as required per 21 CFR 1.512(b)(1)(i). You are also still required to comply with the requirements in sections 1.502, 1.503, and 1.509. However, 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 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 (see 21 CFR 1.512(b)(3)(i)).

The above violation is 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 FSVPs, 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: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Ms. Jung-Lau via email at Juliane.Jung-Lau@fda.hhs.gov. Please reference CMS # 678902 on any documents or records you provide to us and on 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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