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WARNING LETTER

Swagath Home Foods LLC MARCS-CMS 594166 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Ravi Modalavalasa
Recipient Title
Managing Partner
Swagath Home Foods LLC

18001 NE 76th St., Ste 120
Redmond, WA 98052-5023
United States

Issuing Office:
Division of West Coast Imports

United States


WARNING LETTER


January 07, 2020

Re: CMS # 594166

Dear Mr. Ravi Modalavalasa:

On September 18, 2019, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at 18001 NE 76th St., Ste 120, Redmond, CA 98052. We also conducted an inspection on February 2, 2018. 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your Black Pepper Powder imported from Subhash Masala Co. Pvt. Ltd., Spiced Chutney Powder imported from MTR Foods Pvt. Ltd., and Potato Chips imported from Pepsico India Holding Pvt. Your firm did not have FSVPs for these 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, and the follow-up inspection on September 18, 2019, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated September 28, 2019, which includes a document entitled “Swagath Foreign Supplier Verification Program Guidelines.” This document states that you intend to undertake certain verification-related steps, such as: verifying FDA’s website for any known banned products for import hazard, “enforc[ing] hazard analysis for each and every product imported,” and “not importing products that are flagged for risk.” However, this response is inadequate because you have not demonstrated that you have performed any FSVP requirements for particular products. We also note that the guidelines you have provided are very general and do not reflect all of the requirements in the FSVP rule.

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.

You should take prompt action to correct the above violations. If you do not promptly correct the violation, 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 Black Pepper Powder manufactured by Subhash Masala Co. Pvt. Ltd., Spiced Chutney Powder manufactured by MTR Foods Pvt. Ltd., and Potato Chips manufactured by Pepsico India Holding Pvt. Ltd. We may place these foods 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 revised 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: William J Park, 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 Compliance Officer William Park via email at william.park@fda.hhs.gov or by calling him at 562-256-9259. Please reference CMS #594166 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/

Dan R. Solis
Division Director
Division of West Coast Imports
U.S. Food and Drug Administration
One World Trade Center, Suite 300
Long Beach, CA 90831

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