- Delivery Method:
- VIA EMAIL AND UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Jae Y. Han
- 7333 LLC
9122 S. Tacoma Way
Lakewood, WA 98499-4406
- Issuing Office:
- Division of West Coast Imports
April 13, 2022
Re: CMS 625974
Dear Mr. Jae Y. Han:
On December 8, 2021 through December 20, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of 7333 LLC at 9122 S. Tacoma Way, Lakewood, Washington 98499-4406. We also conducted an inspection on February 10, 2021 through February 19, 2021. 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 following foods you import: (b)(4) Scorched Barley imported from (b)(4) located in (b)(4); Frozen Dumpling imported from (b)(4) located in (b)(4); Macaroni imported from (b)(4) located in (b)(4); and Rice Noodle Soup imported from (b)(4) located in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the most recent inspection, our investigator provided you with a Form FDA 483a, FSVP Observations on December 20, 2021. We acknowledge receipt of your response dated January 1, 2022, and we address your response below.
In your response, you “estimate that it may take 8 to 12 months to gather and review information, and complete the FSVP.” You also provided an Excel spreadsheet containing examples of information that you are collecting from your vendors. These documents appear to be related to a red pepper powder product that was not covered during our inspection and include a Certificate of HAACP and SGS Certificate of Registration, as well as documents not translated to English. We are unable to evaluate the adequacy of your response because some of the documents have not been translated to English and you have not provided any supporting documentation or records demonstrating your planned or completed corrective actions with respect to the products covered during the inspection.
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:
- (b)(4) Scorched Barley imported from (b)(4)
- Frozen Dumpling imported from (b)(4)
- Macaroni imported from (b)(4)
- Rice Noodle Soup imported from (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 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 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. Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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 K. Capron, Compliance Officer, Division of West Coast Imports, 22215 26th Ave SE Suite 210, Bothell, WA 98021-4425.
If you have any questions regarding this letter, you may contact Lisa K. Capron via email at Lisa.Capron@fda.hhs.gov. Please reference CMS 625974 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports