Two Importers Issued Warning Letters for Not Having FSVP

Two importers were issued Warning Letters by FDA for not having FSVP programs.  FDA is focusing more enforcement attention on food importers with the requirement for having a foreign supplier verification program (FSVP) as required as part of the FSMA regulation, specifically  21 CFR part 1 subpart.

Swagath Home Foods LLC of WA did not have FSVPs for for Black Pepper Powder imported from Subhash Masala Co. Pvt. Ltd., Spiced Chutney Powder imported from MTR Foods Pvt. Ltd., and Potato Chips imported from Pepsico India Holding Pvt.

Dinamix Distribution, LLC, was TX was not in compliance with the requirements of 21 CFR part 1 subpart L - did not have FSVPs for the following imported products: mayonnaise; tomatoes-spice flavored drink; and punch flavored soft drinks imported from (b)(4).

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swagath-home-foods-llc-594166-01072020
Swagath Home Foods LLC 
MARCS-CMS 594166 — January 07, 2020

Delivery Method:United Parcel Service Product:Food & Beverages
Recipient:
Ravi Modalavalasa
Managing Partner
Swagath Home Foods LLC
18001 NE 76th St., Ste 120
Redmond, WA 98052-5023
United States

Issuing Office:Division of West Coast Imports
United States

WARNING LETTER
 January 07, 2020

Re: CMS # 594166

Dear Mr. Ravi Modalavalasa:

On September 18, 2019, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at 18001 NE 76th St., Ste 120, Redmond, CA 98052. We also conducted an inspection on February 2, 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 Foreign Supplier Verification Program (FSVP) implementing 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 were not in compliance with the requirements of 21 CFR part 1 subpart L for your Black Pepper Powder imported from Subhash Masala Co. Pvt. Ltd., Spiced Chutney Powder imported from MTR Foods Pvt. Ltd., and Potato Chips imported from Pepsico India Holding Pvt. Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection, and the follow-up inspection on September 18, 2019, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated September 28, 2019, which includes a document entitled “Swagath Foreign Supplier Verification Program Guidelines.” This document states that you intend to undertake certain verification-related steps, such as: verifying FDA’s website for any known banned products for import hazard, “enforc[ing] hazard analysis for each and every product imported,” and “not importing products that are flagged for risk.” However, this response is inadequate because you have not demonstrated that you have performed any FSVP requirements for particular products. We also note that the guidelines you have provided are very general and do not reflect all of the requirements in the FSVP rule.

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 the violation, 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 Black Pepper Powder manufactured by Subhash Masala Co. Pvt. Ltd., Spiced Chutney Powder manufactured by MTR Foods Pvt. Ltd., and Potato Chips manufactured by Pepsico India Holding Pvt. Ltd. We may place these foods 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 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: William J Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have

 any questions regarding this letter, you may contact Compliance Officer William Park via email at william.park@fda.hhs.gov or by calling him at 562-256-9259. Please reference CMS #594166 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/

Dan R. Solis
 Division Director
 Division of West Coast Imports
 U.S. Food and Drug Administration
 One World Trade Center, Suite 300
 Long Beach, CA 90831

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dinamix-distribution-llc-594265-12122019

Dinamix Distribution, LLC. 

MARCS-CMS 594265 — December 12, 2019 

Recipient:

Mr. Rodulfo Suarez

Owner 

Dinamix Distribution, LLC.

2101 West Military Highway Suite 1-6

McAllen, TX 78503

United States

Issuing Office:Division of Southwest Imports

United States

December 12, 2019

WARNING LETTER

 Re: CMS # 594265

Dear Mr. Suarez

On June 28, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at your facility, Dinamix Distribution, LLC, located at 2101 West Military Highway, Suite 1-6; McAllen, TX 78503. We also conducted an inspection of a firm you previously operated (b)(4), (b)(6), on (b)(4), (b)(6). 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 Foreign Supplier Verification Program (FSVP) implementing 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.fdagov/Food/GuidanceRegulation/FSMA/ucm361902.htmExternal Link Disclaimer.

During the most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for the following products that you import from your foreign suppliers: mayonnaise; tomatoes-spice flavored drink; and punch flavored soft drinks imported from (b)(4). Your firm did not have FSVPs for these products. 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 response dated August 08, 2019, to the FDA 483a FSVP observations issued on June 28, 2019, which included information listing your vendors and clients. However, your response did not address the lack of FSVPs for the products that you import.

Your significant violations are described below:

You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part I subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:

•mayonnaise manufactured by (b)(4)

•tomatoes-spice flavored drink (b)(4) manufactured by (b)(4) and

•punch flavored soft drinks manufactured by (b)(4)

(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.

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 mayonnaise manufactured by (b)(4), tomatoes-spice flavored drink ((b)(4)) manufactured (b)(4)., and punch flavored soft drinks manufactured by (b)(4). We may place these foods 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 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 your products 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: Lisa M Puttonen, Compliance Officer, Division of Southwest Imports, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions regarding this letter, you may contact CO Puttonen via email at Lisa.puttonen@fda.hhs.gov, Please reference CMS # 594265 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/

Todd Cato

 District Director

 Division of Southwest Imports