Georgia importer warned about violations of federal law

As part of its enforcement activities, the Food and Drug Administration issues warning letters to entities under its jurisdiction. Some letters are not published publicly for several weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until the company has been given months or years to correct the problems.

Ocho Rios Atlanta Inc.
Tucker, Georgia

In a warning letter dated Oct. 24 and made public Nov. 18, the Food and Drug Administration cited the following violations at Ocho Rios Atlanta Inc. in Tucker, Georgia.

From September 18 to 30, 2025, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Ocho Rios Atlanta Inc., located at 1989 Tucker Industrial Rd., Tucker, Georgia. We also conducted inspections on August 27, 2018; November 1, 2019; from July 7 to September 17, 2021; from June 14 to June 27, 2023; and January 31, 2024 through February 6, 2024. These reviews were conducted to determine compliance with Section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and implementation of the FSVP provisions at 21 CFR Part 1 Subpart L.

The FSVP regulation requires importers to perform certain risk-based steps to verify that the human and/or animal food they import into the United States was produced in a manner that meets applicable U.S. food safety standards.

During our most recent inspection, we found that you are not in compliance with 21 CFR Part 1 Subpart L for the following products you import: Spice and seasoning blends. (edited) V (edited); brown sauce from (edited) V (edited); juice drinks from (edited) V (edited); and tea from (edited) V (edited). Because of these serious violations, you are not in compliance with Section 805 of the FD&C Act.

Upon completion of the review, our investigator will provide you with an FDA Form 483a FSVP Observations.

We acknowledge receipt of your response dated October 2, 2025, in which you stated that your designee will develop and implement FSVP plans for all imported food products for which your firm has determined that there is no FSVP. No time frame was given.

We cannot evaluate the adequacy of your response because you have not provided any supporting documentation to support your corrective actions for all imported food items that your firm determines do not have FSVP. To date, the FDA has not received any additional FSVP documents.

You have not developed, maintained, or complied with an FSVP as required by Section 805 of the FD&C Act and 21 CFR Part 1.502(a).

The full text of the warning letter is available Here.

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