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WARNING LETTER

Kyawkhin Inc. MARCS-CMS 666164 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Kyaw Khin
Recipient Title
Owner
Kyawkhin Inc.

2203 Lafayette St.
Fort Wayne, IN 46803-3327
United States

Issuing Office:
Division of Northern Border Imports

United States

Secondary Issuing Offices

United States


Date: September 20, 2023

WARNING LETTER

Re: CMS # 666164

Dear Mr. Kyaw Khin

On August 15 through August 17, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Kyawkhin Inc., located at 2203 Lafayette Street, Fort Wayne, IN 46803-3327. This inspection was 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.

During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection on August 17, 2023, our investigators provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA-483a issued on August 17, 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 any foods that you import, including the following foods:

  • Balachong fried chili paste imported from (b)(4), located in (b)(4)
  • Peanut snack imported from (b)(4), located in (b)(4)
  • Cypro tone beverage base imported from (b)(4), located in (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 with 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 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)).

Additionally, we offer the following comment:

We note that, based on information available to FDA, you may meet the definition of a very small importer under 21 CFR 1.500. If you meet the definition of a very small importer, you may choose to comply with the modified requirements in 21 CFR 1.512. Under 21 CFR 1.512(b)(1)(i), you must document that you meet the definition of very small importer. In addition, under 21 CFR 1.512(b)(2), you are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. Further, under 21 CFR 1.512(b)(3)(i), for each food you import, you must obtain written assurance, 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 .

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: Mark Kaspar, Compliance Officer, DNBI, USFDA, 550 W Jackson, 8th Floor Chicago IL 60661. If you have any questions regarding this letter, you may contact Mark Kaspar via email at mark.kaspar@fda.hhs.gov. Please reference CMS # 666164 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/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports

cc: Mr. Kyaw Khin
Kyawkhin, Inc.
2203 Lafayette St.
Fort Wayne, IN 46803-3327
kyawkhinusa@gmail.com

 
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