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  5. North30 LLC - 633737 - 06/24/2022
  1. Warning Letters

WARNING LETTER

North30 LLC MARCS-CMS 633737 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Elaine (Xaio) Song
Recipient Title
Owner
North30 LLC

15552 Lake Hills Blvd # F-5
Bellevue, WA 98007-5928
United States

Issuing Office:
Division of West Coast Imports

United States

June 24, 2022

WARNING LETTER

Re: CMS # 633737

Dear Ms. Song:

On March 14 through April 8, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of North30 LLC, located at 15552 Lake Hills Blvd # F-5 Bellevue, WA 98007-5928. We also conducted an inspection April 16 through May 7, 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 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 this significant violation, 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 Form FDA 483a issued on April 8, 2022.

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 food products:

  • Passion Fruit Sauce, imported from (b)(4), located in (b)(4)
  • Taro, imported from (b)(4) located in (b)(4)
  • Mesona Extract, imported from (b)(4), located in (b)(4)

We acknowledge that during the most recent inspection, you told our investigator that your firm is expecting to transition to a model where the foods are imported by your franchise office in (b)(4) and then your firm would receive the foods after importation. As of the date of this letter, we have not received any information regarding your FSVPs or planned corrective actions. According to our records, your firm continued to import food following the end of the inspection on April 8, 2022.

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 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: Marcus Fairconnetue, Compliance Officer, Division of West Coast Imports, 22215 26th Avenue Southeast, Suite 210, Bothell, Washington, 98021, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Mr. Fairconnetue via email marcus.fairconnetue@fda.hhs.gov Please reference CMS #633737 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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