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.
The U.S. Food and Drug Administration has issued warning letters to four companies — Zest US Wholesale Inc., Xin Ao International Group Corp., Gongora USA Corp., and San Juan Produce LLC — for significant violations of the Foreign Supplier Verification Program (FSVP). The FSVP regulation requires importers to verify that food imported into the United States meets U.S. safety standards, ensuring conditions equivalent to domestic regulatory requirements. These letters highlight ongoing noncompliance despite prior inspections and opportunities to address issues.
Zest US Wholesale Inc.
Anaheim, CA
The FDA conducted an FSVP inspection of Zest US Wholesale Inc., located in Anaheim, CA, on April 28. The inspection revealed that the company failed to develop, maintain, or follow an FSVP for any of its imported foods, including milk chocolate bars with peanuts, pistachio spread cream and coconut almond truffles from foreign suppliers.
At the conclusion of the inspection, the FDA issued a Form FDA 483a outlining the violations, but the company has not responded. Additionally, the FDA noted that Zest US Wholesale’s facility is subject to food facility registration requirements, which it has not fulfilled despite being advised during the inspection.
The full warning letter can be viewed here.
Xin Ao International Group Corp.
Staten Island, NY
From April 23 to May 6, the FDA inspected Xin Ao International Group Corp. in Staten Island, NY, following a prior inspection in May 2023. The agency found that the company did not develop an FSVP for its imported foods, including seafood mushrooms and enoki mushrooms from foreign suppliers.
A Form FDA 483a was issued on May 6, but no response has been received. The FDA warned that continued noncompliance could lead to detention of imported products without physical examination under Import Alert #99-41.
The full warning letter can be viewed here.
Gongora USA Corp.
Chula Vista, CA
The FDA inspected Gongora USA Corp., located at 355 K St. Suite F, Chula Vista, CA, from Nov. 14 to 15, 2024, following an earlier inspection between December 2020 and January 2021. The company failed to develop an FSVP for its imported fresh produce, including fresh cucumbers, fresh white squash, and fresh cue ball squash.
A Form FDA 483a was issued on Nov. 15, 2024, with no response from the company. The FDA noted that some of Gongora’s imports may be “covered produce” under the Produce Safety Rule, requiring verification of supplier compliance with U.S. safety standards.
The full warning letter can be viewed here.
San Juan Produce LLC
McAllen, TX
On March 25, the FDA conducted an FSVP inspection of San Juan Produce LLC in McAllen, TX, following a prior inspection in May 2023. The company did not develop an FSVP for its imported fresh produce, including Husk Tomatoes, Carrots and Cilantro.
A Form FDA 483a was issued, but no response has been received. The FDA highlighted that some imports may be “covered produce” under the Produce Safety Rule and noted that the company’s facility has not met food facility registration requirements. San Juan Produce indicated it may qualify as a “very small importer,” but failed to provide documentation to support this status or comply with modified requirements.
The full warning letter can be viewed here.
FDA’s concerns
The FDA emphasized that these companies’ failures to comply with FSVP regulations could allow unsafe food to enter the U.S. market. Noncompliance may result in refusal of admission for implicated products, detention without physical examination, and further regulatory actions. Importing food without a compliant FSVP is a prohibited act under federal law. The agency urged all four companies to take immediate corrective action to ensure compliance with the Federal Food, Drug, and Cosmetic Act and the FSVP regulation.
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