The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not made visible to the public until weeks or months after they are sent. Business owners have 15 days to respond to warning letters from the FDA. Warning letters are often only issued after a company has been given months or years to resolve problems.
The U.S. Food and Drug Administration (FDA) recently sent warning letters to two companies, Warbucks Seafood NY LLC and Dasada Group LLC, for failing to meet Foreign Supplier Verification Program (FSVP) requirements. These violations, which concern the companies’ responsibilities to ensure imported food meets U.S. safety standards, were found during inspections earlier this year.
Warbucks Seafood NY LLC
Brooklyn, NY
In a warning letter dated July 24, 2024, the FDA cited Warbucks Seafood NY LLC, based in Brooklyn, NY, for failing to develop or maintain a Foreign Supplier Verification Program for multiple products they import, including truffles, vanilla pods and olive oil flavored with white truffle. The company failed to ensure that these products were produced under conditions that comply with U.S. food safety regulations.
The FDA conducted inspections from February 28 through April 1, 2024, as well as in 2022, and found that Warbucks Seafood NY LLC had not implemented the necessary risk-based activities to verify food safety practices for the imported products. The company did not respond to the FDA 483a form issued at the end of the inspection.
The FDA warned that further action, including placing the company’s imported products under “Detention Without Physical Examination” (DWPE), could occur if the violations are not corrected.
The full warning letter can be viewed here.
Dasada Group LLC
Houston, Texas
The FDA issued a warning letter to Dasada Group LLC, a Houston-based importer, on August 1, 2024, for failing to establish an FSVP for fresh produce, including Dominico bananas, habanero peppers and plantains. These products, imported from suppliers abroad, were found to lack verification of the safety practices required under U.S. law.
During its most recent inspection on June 26, 2024, and a previous inspection in December 2022, the FDA found that Dasada Group had not developed an FSVP for any of the food products it imports. The company also failed to comply with registration requirements for food facilities under the Federal Food, Drug, and Cosmetic Act.
The FDA emphasized the importance of complying with the FSVP to protect consumers and ensure that imported foods meet U.S. public health standards. If the company does not address the violations, their imported products may be detained without physical examination.
The full warning letter can be viewed here.
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