- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameTerry Nguyen
- Kim Nhung Marketplace Inc
1239 S King St
Seattle, WA 98144-2024
- Issuing Office:
- Division of West Coast Imports
October 1, 2021
Re: CMS 616346
Dear Mr. Terry Nguyen:
From May 5 to 21, 2021 the Food and Drug Administration conducted a Foreign Supplier Verification Programs (FSVP) inspection of FSVP records that you submitted to FDA electronically for Kim Nhung Marketplace Inc.1239 S King St Seattle, WA 98144-2024. We also conducted an inspection on March 20, 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/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 were not in compliance with the requirements of 21 CFR part 1 subpart L for: Frozen Taro, Frozen Steam Sweet Corn (with Husk) and Frozen Tapioca Noodle imported from (b)(4) and the (b)(4) Rice (b)(4) imported from (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on March 20, 2019 and the follow-up inspection on May 21, 2021 our investigator provided you in each instance with a Form FDA 483a FSVP Observations.
We acknowledge receipt of your response dated June 21, 2021, and we address your response below.
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). Specifically, your firm did not develop an FSVP for each of the following foods:
• Frozen Taro imported from (b)(4).
• Frozen Steam Sweet Corn (with Husk) imported from (b)(4).
• Frozen Tapioca Noodle imported from (b)(4).
• (b)(4) Rice (b)(4) 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.
You should take prompt action to correct the above violations. If you do not promptly correct them, 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. 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.
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 these violations. You should include in your response documentation and information that will assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised 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 the foods you import 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: Steven L. Robbs, Compliance Officer, Division of West Coast Imports, One World Trade Center 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Steven Robbs via email at firstname.lastname@example.org. Please reference CMS 616346 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports
One World Trade Center, Suite 300
Long Beach, CA 90831