WARNING LETTER
Ocho Rios Atlanta Inc.
MARCS-CMS 718580 —
October 24, 2025
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Aston Lue
Recipient Title
President and Owner
Ocho Rios Atlanta Inc.
1989 Tucker Industrial Rd.
Tucker
,
GA
30084-6640
United States
(b)(6), (b)(7)(C)
Issuing Office:
Division of Southeast Imports
United States
October 24, 2025
WARNING LETTER
RE: CMS# 718580
Dear Mr. Aston Lue:
From September 18th to 30th, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Ocho Rios Atlanta Inc., located at 1989 Tucker Industrial Rd., Tucker, GA 30084-6640. We also conducted inspections on August 27th, 2018; November 1st, 2019; July 7th through September 17th, 2021; June 14th through 27th, 2023; and January 31st through February 6th, 2024. 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 following foods you import: Mixed spices and seasonings
(b)(4)
in
(b)(4)
; Brown sauce from
(b)(4)
in
(b)(4)
; Juice drinks from
(b)(4)
in
(b)(4)
; and Tea from
(b)(4)
in
(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 inspection, our investigator provided you with a Form FDA 483a FSVP Observations.
We acknowledge receipt of your response, dated October 2, 2025, in which you stated your Qualified Individual will develop and implement FSVP plans for all the imported foods that your firm identified as not having an FSVP in place. No timeframes were provided. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions for all the imported foods that your firm identified as not having an FSVP in place. 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 CFR part 1.502(a). Specifically, you did not develop an FSVP for the following foods you import:
Mixed spices and seasonings
(b)(4)
imported from
(b)(4)
, located in
(b)(4)
Brown sauce imported from
(b)(4)
, located in
(b)(4)
Juice drinks imported from
(b)(4)
, located in
(b)(4)
Tea imported 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.
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: Allison McGloin, Compliance Officer, Division of Southeast Imports: OIIOIODSEIFirmCorrespondence@fda.hhs.gov. Please also cc (carbon copy) Allison.McGloin@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer McGloin via email at Allison.McGloin@fda.hhs.gov. Please reference CMS # 718580 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Christopher Boulmay
Acting Program Division Director
Division of Southeast Imports
Content current as of:
11/18/2025
Regulated Product(s)
Food & Beverages