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  5. BC Food LA, LLC, DBA B & C Food Co. - 654872 - 07/24/2023
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WARNING LETTER

BC Food LA, LLC, DBA B & C Food Co. MARCS-CMS 654872 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Allen L. Pung
Recipient Title
Owner/Manager
BC Food LA, LLC, DBA B & C Food Co.

2662 Seaman Avenue
El Monte, CA 91733-1930
United States

Issuing Office:
Division of West Coast Imports

United States

Secondary Issuing Offices

United States


July 24, 2023

WARNING LETTER

Re: CMS 654872

Dear Mr. Allen L. Pung:

From February 13 to 23, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of BC Food LA, LLC, DBA B & C Food Co., located at 2662 Seaman Avenue, El Monte, CA. We also conducted an inspection on July 11, 2019 and on July 9 to 14, 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

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 foods from the foreign suppliers indicated in the list provided during the inspection. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on February 23, 2023.

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, you did not develop an FSVP for the foods you import indicated in the list provided during the inspection, including the following foods:

  • Cookie, imported from (b)(4), located in (b)(4)
  • Duck eggs, imported from (b)(4), located in (b)(4)
  • Gourd, imported from (b)(4), located in (b)(4)
  • Fruit filled cookies, plain cookies, biscuits, wafers and cakes and other, imported from (b)(4), located in (b)(4)
  • Nut plain cookies, biscuits and wafers, imported from (b)(4) located in (b)(4)
  • Fruit filled cookies, biscuits wafters, filled, iced cookies, imported from (b)(4), located in (b)(4)
  • Noodles wheat and soy, imported from (b)(4), located in (b)(4)
  • Bean Thread, 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.

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 with the opportunity to promptly correct the above violations. 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 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 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, 19701 Fairchild Road, Irvine, California, 92612. 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 654872 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/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

 
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