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  5. Bharat Ratan LLC - 634674 - 08/22/2022
  1. Warning Letters

WARNING LETTER

Bharat Ratan LLC MARCS-CMS 634674 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ashok K. Monga
Recipient Title
Owner
Bharat Ratan LLC

19030 116th Ave. SE
Renton, WA 98058-7159
United States

Issuing Office:
Division of West Coast Imports

United States

August 22, 2022

WARNING LETTER

Re: CMS # 634674

Dear Mr. Monga:

On April 5, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Bharat Ratan LLC. located at 19030 116th Ave. SE Renton, WA 98058-7159. We also conducted inspections on December 20, 2019 and September 14, 2020. 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 you import. Because of these significant violations, your firm is 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 April 14, 2022.

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 foods you import, including:

  • Fenugreek leaves, Gur Rewri (Sesame Brittle), and Punjabi Biscuit, imported from (b)(4), located in (b)(4)
  • Meat Masala (Curry Spice Mix) 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.

Additionally, we also offer the following comments:

During our most recent inspection, you told our investigator that you qualified as a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer on an annual basis as required per 21 CFR 1.512(b)(1)(i). In addition we note, 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. You may find information on documenting your eligibility as a very small importer and the other requirements under 21 CFR 1.512 in the “Draft Guidance for Industry Foreign Supplier Verification Programs for Imports of Food for Human and Animals at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals.

In addition, FDA has determined that your facility at 19030 116th Ave. SE Renton, WA 98058-7159 is subject to the registration requirement in section 415 of the FD&C Act (21 U.S.C. § 350 d) and our implementing regulations at 21 CFR Part 1, Subpart H. Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. During the inspection you were advised of these requirements. Our records indicate that as of the date of this letter, your firm does not have a valid food facility registration. The failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. § 331(dd)).

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 workings days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).

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 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: Marcus Fairconnetue, Compliance Officer, Division of West Coast Imports, One World Trade Center Suite 300, Long Beach, CA 90831 with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Mr. Fairconnetue via email marcus.fairconnetue@fda.hhs.gov Please reference CMS # 634674 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

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