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  5. Dinamix Distribution, LLC. - 594265 - 12/12/2019
  1. Warning Letters

WARNING LETTER

Dinamix Distribution, LLC. MARCS-CMS 594265 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Rodulfo Suarez
Recipient Title
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.

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 

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