WARNING LETTER
Grupo Rm Usa, Inc.
MARCS-CMS 609291 —
August 06, 2020
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Luis A. Zeledon
Recipient Title
President
Grupo Rm Usa, Inc.
7991 NW 82nd Ave.
Miami
,
FL
33166-2749
United States
Issuing Office:
Division of Southeast Imports
United States
WARNING LETTER
Re: CMS # 609291
Dear Mr. Zeledon:
On April 21, April 30, and May 6, 2020, the U.S. Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Grupo RM USA, Inc., located at 7991 NW 82nd Ave. Miami, FL 33166. We also conducted an initial on-site FSVP inspection on May 08, 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 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 food products you import, including, but not limited to, Tropical Banana Soft Drink imported from
(b)(4)
; and Milk Candy imported from
(b)(4)
. You did not have FSVPs for these products or any food products that you import. 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 in 2018 and the follow-up inspection in 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.We have not received your response to either Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
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 FSVPs for the food products that you import, including, but not limited to:
• Tropical Banana Soft Drink, imported from
(b)(4)
.
• Toasted Crackers, imported from
(b)(4)
.
• Milk Candy, imported from
(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)
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)
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 the food products you import. We may place the foods you import 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., 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 # 609291 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
Content current as of:
08/25/2020
Regulated Product(s)
Food & Beverages