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  5. R.R. Importaciones Inc. - 719593 - 12/30/2025
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WARNING LETTER

R.R. Importaciones Inc. MARCS-CMS 719593 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Rogelio Martinez
Recipient Title
President and Owner
R.R. Importaciones Inc.

141 3rd Street # 143
Passaic, NJ 07055
United States

Issuing Office:
Office of Inspections and Investigations

United States

WARNING LETTER

RE: CMS# 719593

Dear Mr. Martinez:

On August 21, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of R. R. Importaciones Inc, located at 141 3rd Street # 143 Passaic, NJ 07055. We also conducted an inspection on October 3, 2023, through October 5, 2023. 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 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 27, 2025, in which you provided (b)(4) and three documents in a foreign language. We are unable to evaluate the adequacy of your response because you have not provide any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA.

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 CFR1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following:

  • (b)(4) from (b)(4), located in (b)(4)
  • (b)(4) from (b)(4), located in (b)(4)
  • Chocolate from (b)(4), located in (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.

(b)(3)(A)

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

(b)(3)(A)

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 into the United States 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: Spiridoula Dimopoulos, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Spiridoul.Dimopoulos@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Dimopoulos via email at Spiridoul.Dimopoulos@fda.hhs.gov. Please reference CMS # 719593 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

CDR Joseph S. Tomao
Program Division Director
Division of Northeast Imports

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