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WARNING LETTER

Krishiv Foods, LLC MARCS-CMS 649471 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Bhavik Patel
Recipient Title
President
Krishiv Foods, LLC

1336 Tamarack Drive
Bartlett, IL 60103-1514
United States

Issuing Office:
Division of Northern Border Imports

United States


Date: April 25, 2023

WARNING LETTER

Re: CMS # 649471

Dear Mr. Bhavik Patel:

On November 30 to December 13, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Krishiv Foods, LLC located at 802 Greenleaf Ave., Elk Grove Village, Illinois, 60007-5026. We also conducted inspections on July 28, 2022, and on May 4 to 14, 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 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 most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: whole nutmeg, moong dal, and whole mustard seed imported from (b)(4) located in (b)(4). Because of these significant violations, you are 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 December 13, 2022.

Your significant violations of the FSVP regulation are as follows:

1. You must conduct a hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504(a). Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During the inspection, you provided copies of your foreign supplier hazard analysis for whole nutmeg, moong dal, and whole mustard seeds imported from (b)(4), located in (b)(4). Although you stated in an email dated December 8, 2022 that you “review and evaluate all hazard analysis (b)(4) or sooner as needed,” you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analyses, as required by 21 CFR 1.504(d).

2. You did not meet the requirement to evaluate your foreign supplier’s performance and the risk posed by the food, and to approve your foreign supplier on the basis of this evaluation, in accordance with 21 CFR 1.505. Specifically, during the inspection, you stated in an email dated December 8, 2022 that you chose named foreign suppliers “based on their market reputation and demand of their products by consumers.” You further stated that your “foreign suppliers are FDA registered and hold various certificates, which makes them trustworthy. They are also focused highly on quality of products and take all feedback very seriously.” However, for your foreign supplier (b)(4), located in (b)(4), you did not document your evaluation of the foreign supplier’s performance and the risk posed by the food in accordance with 21 CFR 1.505(a)(2), or document your approval of the foreign supplier, as required by 21 CFR 1.505(b).

3. You did not meet the requirement to conduct (and document) or obtain documentation of one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, in accordance with 21 CFR 1.506(e). Specifically, you did not conduct (and document) or obtain documentation of one or more such supplier verification activities for your foreign supplier (b)(4), located in (b)(4), before importing whole nutmeg, moong dal, and whole mustard seeds. During the inspection, you stated in an email dated December 8, 2022: “we (b)(4) audit each shipment and (b)(4) check items sent by foreign suppliers. We also follow the food safety plan to make sure that these items are ready to be consumed by consumers. Items that are on import alert are lab tested to assure the quality.” However, you did not provide documentation of verification activities for moong dal and whole mustard seeds. You responded to our investigator’s request for verification records by providing documents sent to U.S. Customs at the time of import entry and asserted that testing is done prior to importation and was reported on one of the documents you provided titled, “Quality Evaluation Laboratory Spices Board Test Report.” However, as our investigator explained, this report did not include testing results for the relevant foods, specifically, nutmeg, moong dal, and mustard seeds. For the whole nutmeg imported from (b)(4), located in (b)(4), which is listed on Import Alert #99-19, “Detention Without Physical Examination of Food Products Due to the Presence of Salmonella,” you provided a laboratory report from (b)(4) with sample results for Salmonella. However, this laboratory report did not include test results for all hazards associated with the whole nutmeg and you did not provide documentation of any other verification activities.

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 from the identified foreign suppliers 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 (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 revised FSVP, records to demonstrate implementation of your revised 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: Mark Kaspar, Compliance Officer, DNBI, USFDA, 550 W Jackson, 15th 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 # 649471 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. Bhavik Patel, President
Krishiv Foods, LLC
1336 Tamarack Drive
Bartlett IL 60103-1514
bhavik@krishivfoods.com

 
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