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  5. Dilip Ceramics Inc. dba Shivam Distributors - 613332 - 05/04/2021
  1. Warning Letters

WARNING LETTER

Dilip Ceramics Inc. dba Shivam Distributors MARCS-CMS 613332 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Nirmal V. Panchal
Recipient Title
Vice President
Dilip Ceramics Inc. dba Shivam Distributors

126 Commerce St.
Longwood, FL 32750-5416
United States

Issuing Office:
Division of Southeast Imports

United States

May 4, 2021

WARNING LETTER

Re: CMS # 613332

Dear Mr. Nirmal V. Panchal:

From December 29, 2020 through January 6, 2021, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically. This inspection was 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for Cumin Powder imported from foreign supplier (b)(4); Red Lentils from foreign supplier (b)(4); and (b)(4) Basmati Rice from foreign supplier (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 FSVP inspection on January 6, 2021, our investigator provided you with a Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a.

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&CAct and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the Cumin Powderyou import from (b)(4).

2. For the Red Lentils you import from your foreign supplier (b)(4), and the (b)(4) Basmati Rice you import from your foreign supplier (b)(4), although you provided documents regarding your foreign supplier, you did not meet your requirements to conduct a hazard analysis in accordance with21 CFR 1.504, you did not evaluate your foreign supplier’s performance in accordance with21 CFR 1.505, nor did you perform foreign supplier verification activities in accordance with21 CFR 1.506.

Specifically, during our inspection, you provided an email dated December 30, 2020, which included several attached documents for your foreign supplier (b)(4), and your foreign supplier (b)(4). For your foreign supplier (b)(4), the documents you provided appear to include a statement on (b)(3)(A), a Non-GMO statement, an allergen policy, a process flow chart, technical specification data sheets for Red Split Lentil and Whole Red Lentil, and a one-page third-party audit certificate from (b)(4) stating that the food safety management system of (b)(4) “has been assessed and determined to comply with the requirements of: Food Safety System Certification FSSC 22000 v4.1.” For your foreign supplier (b)(4), the documents you provided appear to include a process flow diagram and a document entitled “Quality Assurance Certificate ((b)(4)),” which states various “characteristics” and “limits” but is an empty form that does not actually state any testing results. You did not provide an explanation or description of how these documents relate to your FSVP program, nor did you provide a record of your review of these documents.

For both of these foreign suppliers, you did not provide a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504. In addition, for both of these foreign suppliers, you did not provide documentation that you have evaluated your foreign supplier’s performance and 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).

You also did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506. You did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities in accordance with 21 CFR 1.506(d). With respect to the requirements of 21 CFR 1.506(e), while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor and that they assessed compliance with FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States). You must also promptly review and assess any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)). Likewise, if you conduct sampling and testing as a verification activity, you must retain documentation of each sampling and testing of a food, including identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical method(s) used), the date(s) on which the test(s) were conducted and the date of the report of the testing, the results of the testing, any corrective actions taken in response to detection of hazards, information identifying the laboratory conducting the testing, and documentation that the testing was conducted by a qualified individual (21 CFR 1.506(e)).

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. Failure to adequately address this matter may result in 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 for which you appear to be in violation of section 805 of the FD&C Act. We may place the foods you import 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.

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 address any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., 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: Coral del Mar Lopez, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Rd. Suite #100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Lopez via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS No. 613332 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/

Ruth Dixon
Program Division Director
Division of Southeast Imports

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