WARNING LETTER
Bhan Kanom Thai Inc
MARCS-CMS 625822 —
March 28, 2022
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Alvin Petcha
Recipient Title
President
Bhan Kanom Thai Inc
3235 N San Fernando Rd Unit 2b,
Los Angeles
,
CA
90065-1434
United States
Issuing Office:
Division of West Coast Imports
United States
March 28, 2022
WARNING LETTER
Re: CMS # 625822
Dear Mr. Petcha:
On December 6, 7, 9, 13, and 14, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Bhan Kanom Thai Inc. located at 3235 N San Fernando Rd Unit 2b, Los Angeles, CA 90065-1434. We also conducted an inspection on July 19, 2021. 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/foodsafety-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 Cookie Rolls - Herbal imported from
(b)(4)
Chip imported from
(b)(4)
in
(b)(4)
Dipping Sauce imported from
(b)(4)
. You did not have FSVPs for these or any of the products you import. 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 July 19, 2021, and the follow-up inspection on December 14, 2021, our investigator provided you with Form FDA 483a, FSVP Observations. We acknowledge your response dated August 3, 2021, in which you stated that you would attend an FSVP class, create FSVPs, and “believe we will be able to finish and become fully compliant by 2022.” As of the date of this letter, we have not received your response to the Form FDA 483a issued on December 14, 2021.
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, maintain, and follow an FSVP for any of the products you import including each of the following food products:
Cookie Rolls - Herbal imported from
(b)(4)
(b)(4)
Chip imported from
(b)(4)
(b)(4)
Dipping Sauce 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. Failure to adequately address this matter may result in 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 products you import. We may place the foods 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 correct these 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, 1 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 #625822 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
Content current as of:
05/03/2022
Regulated Product(s)
Food & Beverages