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WARNING LETTER

Sky Global Food Inc MARCS-CMS 613090 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Yoon K. Lee
Recipient Title
Owner
Sky Global Food Inc

722 S. Alameda St.
Los Angeles, CA 90021
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

March 24, 2021

Re: CMS # 613090

Dear Ms. Yoon K. Lee:

On December 22 and 23, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Sky Global Food, Inc., located at 722 S. Alameda St. Los Angeles, CA 90021. We also conducted an inspection on September 6, 2018. 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 Foreign Supplier Verification Program (FSVP) implementing 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 our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import, including Dried Red Chili Pepper Powder imported from foreign supplier (b)(4), Wheat Noodle imported from foreign supplier (b)(4), Dried Eggplant imported from foreign supplier (b)(4). Because of these significant violations, your firm is not in compliance with section 805 of the FD&C Act.

At the conclusion of the FSVP inspection, our investigator provided your firm with Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a issued on December 23, 2020.

Your significant deviation is described below:

1. 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 stated that you did not develop an FSVP for any foods that you import, including:

  • Dried Red Chili Pepper Powder imported from your foreign supplier (b)(4)
  • Wheat Noodle imported from your foreign supplier (b)(4)
  • Dried Eggplant imported from your foreign supplier (b)(4)

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. Failure to adequately address this matter may lead to regulatory 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 products you import that appear to be in violation of section 805. We may place the food products 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.

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 address 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 your products 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: Lin Liu, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Mr. Lin Liu via email at lin.liu@fda.hhs.gov. Please reference CMS # 613090 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/

Lawton W. Lum
Acting Program Division Director
Division of West Coast Imports

 
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