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  1. Warning Letters

WARNING LETTER

Premier Food Supplies LLC MARCS-CMS 656160 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Jagdish Rughani
Premier Food Supplies LLC

1783 Thunderbird
Troy, MI 48084-5465
United States

Issuing Office:
Division of Northern Border Imports

United States

07/14/2023

WARNING LETTER

Re: CMS #656160

Dear Mr. Jagdish Rughani:

On March 14 through March 23, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Premier Food Supplies LLC, located at 1783 Thunderbird Troy, MI 48084-5465. We also conducted inspections on July 16, 2020 and September 12, 2017. 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 from the foreign suppliers indicated in the attached list and for the Boondi Plain (Boondi Salted) and the Nimbu Masala imported from Haldiram Snacks Pvt. Ltd., located in India, and the Cut Mango Pickle with Garlic 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 acknowledge receipt of your written response dated April 10, 2023, and we address your response below.

Your significant violations of the FSVP regulation are as follows:

1. 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 the foods from the foreign suppliers indicated in the attached list.

On April 10, 2023, you emailed our investigator a variety of documents, including your FSVP compliance manual, an SOP on reviewing a hazard analysis, an SOP on reviewing compliance status, and an SOP on determining appropriate verification activities. These documents appear to be general SOPs on how to establish FSVPs for the foods you import, but your response did not include any documents regarding the specific foods and foreign suppliers indicated in the attached list. Thus, the documents you provided, on their own, do not constitute an FSVP for the identified foods and foreign suppliers, as required by section 805 of the FD&C Act and 21 CFR 1.502(a).

2. You did not meet the requirement to conduct a written 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. 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)). Specifically, for your Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd., located in India, while you obtained the hazard analysis for each of these products from your foreign supplier, you did not document your review and assessment of the hazard analyses or that the hazard analyses were conducted by a qualified individual, as required under 21 CFR 1.504(d).

In your written response dated April 10, 2023, you provided a document titled, “SOP Reviewing Hazard Analysis”; however, your response did not include documentation of your review and assessment of the hazard analyses you obtained from your foreign supplier for your Boondi Plain (Boondi Salted) and Nimbu Masala. Likewise, although your response included a letter to your foreign supplier asking them to share the list of their qualified individuals and what makes them qualified, to date, you have not provided documentation that the hazard analyses were conducted by a qualified individual.

3. You did not meet the requirement to evaluate your foreign supplier’s performance and the risk posed by the food, as required by 21 CFR 1.505(a), and document your approval of your foreign suppliers based on this evaluation, as required by 21 CFR 1.505(b). Specifically, for your Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd., located in India, and Cut Mango Pickle with Garlic imported from (b)(4), located in (b)(4), you did not provide documentation that you have evaluated your foreign supplier’s performance and the risk posed by the food, as required by 21 CFR 1.505(a), or your approval of these suppliers, as required by 21 CFR 1.505(b).

In your written response dated April 10, 2023, you provided a document titled, “SOP Review compliance status”; however, your response did not include documentation that you have evaluated your foreign supplier’s performance and the risk posed by the food for your Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. or your Cut Mango Pickle with Garlic imported from (b)(4).

4. You did not meet the requirement to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, you did not document your determination of the appropriate supplier verification activity or activities, including the frequency with which the activity or activities must be conducted, for your Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. and Cut Mango Pickle with Garlic imported from (b)(4), as required by 21 CFR 1.506(d), nor did you conduct (and document) or obtain documentation of one or more appropriate supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter, as required by 21 CFR 1.506(e).

In your response dated April 10, 2023, you provided a document titled, “SOP Determine the appropriate Verification Activities”; however, your response did not include information related to your determination of appropriate verification activities for these foreign suppliers or documentation of any verification activities that you conducted or reviewed for these foreign suppliers.

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 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 from the identified foreign suppliers 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 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: Alyssa Wenke, Compliance Officer, Division of Northern Border Imports, at Alyssa.Wenke@fda.hhs.gov. If you have any questions regarding this letter, you may contact CO Wenke via email. Please reference CMS #656160 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

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