FDA warns two companies over foreign supplier verification violations

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 FDA has issued warning letters to two companies for failing to comply with the Foreign Supplier Verification Program (FSVP), which requires importers to ensure that foreign food suppliers meet U.S. safety standards.

The letters, sent to Talla Imports LLC and Premium Fresh Growers LLC, highlight repeated failures to establish and implement FSVP procedures for various imported food products, including chocolate, cookies, fresh produce and candy.

Talla Imports LLC
Burnsville, MN

Minnesota-based Talla Imports LLC received a warning letter on Jan. 13, 2025, after FDA inspections conducted from Nov. 20 to Dec. 16, 2024, found the company had not developed or maintained an FSVP for any of its imported foods. The company imports products such as chocolate toffee, gingerbread cookies and fruit candy sticks from Sweden.

At the conclusion of the inspection, FDA investigators issued a Form 483a detailing the firm’s noncompliance, but Talla Imports did not respond. The FDA warned that failure to correct these violations could result in detention without physical examination (DWPE), which would prevent the company’s imports from entering the U.S.

The full warning letter can be viewed here.

Premium Fresh Growers LLC
McAllen, TX

Texas-based Premium Fresh Growers LLC received a warning letter on Dec. 18, 2024, following an inspection conducted from Oct. 24 to Nov. 25, 2024. The company, which also failed an earlier inspection between May and July 2023, imports limes, cilantro and carrots from foreign suppliers but has not implemented an FSVP to ensure these products meet U.S. safety standards.

The FDA noted that the company’s failure to develop and maintain an FSVP is particularly concerning because fresh produce can pose a high risk for contamination. Investigators issued a Form 483a at the end of the inspection, but Premium Fresh Growers has not provided a response.

The FDA warned that continued violations could result in import refusals and placement on an import alert, which would subject shipments to detention without physical inspection.

The full warning letter can be viewed here.

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