The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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 (FDA) has recently issued warning letters to two companies, Warbucks Seafood NY LLC and Dasada Group LLC, for failing to comply with the Foreign Supplier Verification Program (FSVP) requirements. These violations, which pertain to the companies’ responsibilities to verify that 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 not developing or maintaining 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 Feb. 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 Form FDA 483a issued at the conclusion 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, TX
The FDA issued a warning letter on Aug. 1, 2024, to Dasada Group LLC, a Houston-based importer, for failing to establish an FSVP for fresh produce, including Dominico bananas, habanero peppers and plantains. These products, imported from suppliers in foreign countries, were found to lack verification of safety practices required under U.S. law.
During the most recent inspection on June 26, 2024, and an earlier inspection in Dec. 2022, the FDA discovered that Dasada Group had not developed an FSVP for any of the food products it imports. The company also failed to comply with food facility registration requirements under the Federal Food, Drug, and Cosmetic Act.
The FDA emphasized the importance of FSVP compliance to protect consumers and ensure that imported food meets U.S. public health standards. If the company does not address the violations, their imported products could face detention without physical examination.
The full warning letter can be viewed here.
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