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WARNING LETTER

Vibrant Enterprise LLC MARCS-CMS 610514 —

Product:
Food & Beverages
Recipient:
Recipient Name
Shirish Dubey
Recipient Title
Owner/CEO
Vibrant Enterprise LLC

24 Melvin Ave
Iselin, NJ 08830
United States

Issuing Office:
Division of Northeast Imports

United States

WARNING LETTER
CMS # 610514

November 24, 2020

Dear Mr. Shirish Dubey:

From July 14 to August 4, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) remote inspection of Vibrant Enterprise, LLC, 501 Finnegan Ln, North Brunswick, New Jersey 08902. We also conducted an inspection on September 13, 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 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-safetymodernization-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 food products you import including, but not limited to, Tamarind Paste, Chatpata Chaat Makhana Pops (Roasted Foxnuts) and Kesar Mango Pulp imported from your foreign supplier (b)(4) for Sarson Ka Saag (Curried Mustard Leaves) imported from your foreign suppliers (b)(4) and (b)(4). You did not have FSVPs for these products or for any 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 both the most recent inspection on August 4, 2020 and the initial FSVP inspection on September 13, 2018, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your emailed response dated August 13, 2020. Your response included a document which describes your brief written responses after each observation on the FDA 483a. However, we are unable to evaluate the adequacy of your response as you did not provide timeframes for completion or any written procedures or documentation of your FSVP activities to show that you have made corrections or developed FSVPs for the foods you import and your foreign suppliers.

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 a FSVP for the foods you import, including but not limited to:

  • Tamarind Paste, Chatpata Chaat Makhana Pops (Roasted Fox Nuts), Kesar Mango Pulp, and canned Sarson Ka Saag (Curried Mustard Leaves) imported from your foreign supplier (b)(4)

Furthermore, for thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods) and with respect to the microbiological hazards associated with these food products, you must verify and document that they were produced in accordance with 21 CFR part 113. Specifically, you did not verify and document that the canned food products you import, including but not limited to Sarson Ka Saag (Curried Mustard Leaves) were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).

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 them, 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 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.

In addition to the above violations, we also have the following comments:

During our inspection you told our investigator that you did not maintain records of any food you import, only requested documents as needed from your foreign suppliers, and did not review the documents. You provided records you received to the investigator on July 23, 2020, including three food safety plans from (b)(4). In so much as you intend to use a foreign supplier’s food safety plans to meet your obligations under the FSVP regulation, you did not provide FDA any evidence you reviewed these records and you told our investigator that you did not review the food safety plans. You may meet your requirement to conduct a hazard analysis as required under 21 CFR 1.504(a) by reviewing and assessing your foreign supplier’s hazard analysis included in their food safety plan and documenting your review and assessment of that hazard analysis, as well as ensure it was conducted by a qualified individual, as required by 21 CFR 1.504(d). The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements.

Furthermore, based upon the information provided in the food safety plan titled, “Food Safety Plan- For Products Involving Controls at Supplier End,” certain products you import are received from other manufacturers by (b)(4) who solely adds a label. These products include Chatpata Chaat Makhana Pops, Kesar Mango Pulp, and Sarson Ka Saag. The foreign supplier of a food as defined in the FSVP regulation is the establishment that manufactures/processes the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature (21 CFR 1.500). Because of this, your foreign supplier for the purposes of the FSVP regulation might not be the entity from which you directly obtain the food you import. If you obtain a food from a foreign warehouse, distributor, broker, or other entity that does not perform any manufacturing/processing of a more-than-de minimis nature, the foreign supplier of the food would be the last entity in the foreign supply chain that conducts significant manufacturing/processing of the food. Consequently, you are responsible for evaluating and approving the foreign supplier and determining appropriate verification activities for the foreign supplier responsible for controlling the hazards and conducting verification activities as appropriate. We note you may approve your foreign supplier based upon information provided by someone else, under 21 CFR 1.505(d), provided you document your approval and determine appropriate verification activities, as required by 21 CFR 1.506(e). You must also maintain documentation of your FSVP processes and procedures, including your foreign supplier approval and verification activities, in accordance with the record keeping requirements under 21 CFR 1.510.

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: Teresa T. Cain, FDA Compliance Officer, Division of Northeast Imports by email to ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) teresa.cain@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Cain via email at teresa.cain@fda.hhs.gov. Please reference CMS # 610514 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/

Dawne Hines
Program Division Director
Division of Northeast Imports

 
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