Georgia importer warned about violations of federal law

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

Ocho Rios Atlanta Inc.
Tucker, GA

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

From Sept. 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, GA. We also conducted inspections on Aug. 27, 2018; Nov. 1, 2019; July 7 through Sept. 17, 2021; June 14th through 27, 2023; and Jan. 31 through Feb. 6, 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. 

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 (redacted) in (redacted); brown sauce from (redacted) in (redacted); juice drinks from (redacted) in (redacted); and tea from (redacted) in (redacted). 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 Oct. 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.

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).

The complete warning letter is available here.

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