WARNING LETTER
Big Vegetarian Supply, Inc.
MARCS-CMS 683421 —
September 26, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Shan H. Lu
Recipient Title
CEO
Big Vegetarian Supply, Inc.
15452 Valley Blvd.
City of Industry
,
CA
91746
United States
Issuing Office:
Division of West Coast Imports
United States
September 26, 2024
WARNING LETTER
Re: CMS #683421
Dear Mr. Lu:
On March 22, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Big Vegetarian Supply, Inc. located at 15452 Valley Blvd., CA 91746. We also conducted an inspection on March 19, 2020 and May 13, 2022. 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.
We acknowledge receipt of your responses to the Form FDA 483a, FSVP Observations dated April 5, 2024 and June 7, 2024, in which your consultant stated they will assist you to develop and implement FSVP Plans for the products listed in the FDA 483a and provide you training become an FSVP Qualified Individual. In your June 7, 2024 response, you included copies of your FSVP for foreign supplier,
(b)(4)
, including documentation that during the previous 3-year period of 2021, 2022 and 2023, your annual average sales of food plus the U.S. market value of food imported, processed, packed, or held without sale was less than $1 million U.S. and that you qualify as a very small importer in accordance with the FSVP regulation, 21 CFR 1.500 and 1.512. Your FSVP also included a written assurance and other documents, such as a HACCP plan and lab reports, from the referenced foreign supplier.
Your significant violations of the FSVP regulations are as follows:
As a very small importer, for each food you import, you must obtain written assurance, in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act. However, you did not provide written assurances from your foreign suppliers for the following foods you import:
a. Frozen
(b)(4)
imported from
(b)(4)
b. Imitation Chicken
(b)(4)
imported from
(b)(4)
c. Chewy Candy Kumquat Flavored 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. 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 from the identified foreign suppliers 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 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: Sundy Sedwick, Compliance Officer, Division of West Coast Imports, 19701 Fairchild, Irvine, CA 92612. If you have any questions regarding this letter, you may contact Sundy Sedwick via email at sundy.sedwick@fda.hhs.gov. Please reference CMS #683421 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
Content current as of:
09/26/2024
Regulated Product(s)
Food & Beverages