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  5. J & L USA Inc. - 613754 - 04/30/2021
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WARNING LETTER

J & L USA Inc. MARCS-CMS 613754 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Sam Sanwei Liang
Recipient Title
General Manager
J & L USA Inc.

6541 E Washington Boulevard
Commerce, CA 90040-1821
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

April 30, 2021

Re: CMS # 613754

Dear Mr. Liang:

On January 19, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm J & L USA Inc., located at 6541 E Washington Blvd., Commerce, CA 90040-1821. We also conducted an inspection on May 31, 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 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 inspections, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for Green Tea and Dried Bamboo Leaf imported from (b)(4); Dried White Fungus imported from (b)(4). Additionally, we found that you are still not in compliance with the requirements of 21 CFR Part 1 subpart L for the Rock Candy and Brown Candy in Pieces imported from (b)(4) from the previous inspection. Your firm did not have FSVPs for these food products. 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 May 31, 2019 and the current inspection on January 19, 2021, our investigator provided you with Form FDA 483a, FSVP Observations. We have not received your response to either Form FDA 483a.

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:

a. Green Tea imported from (b)(4), located in (b)(4)
b. Dried Bamboo Leaf imported from (b)(4), located in (b)(4)
c. Dried White Fungus imported from (b)(4), located in (b)(4)
d. Rock Candy imported from (b)(4), located in (b)(4)
e. Brown Candy in Pieces imported from (b)(4), located in (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 address this matter adequately 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 Green Tea and Dried Bamboo Leaf imported from (b)(4); Dried White Fungus imported from (b)(4); and Rock Candy and Brown Candy in Pieces imported from (b)(4) that appear to be in violation of section 805. We may place these foods you import from the identified foreign suppliers 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 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: Nabeela J. Chaudhry, 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 Nabeela Chaudhry via email at nabeela.chaudhry@fda.hhs.gov. Please reference CMS #613754 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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