FDA cites Eurobread for import failures behind Salmonella outbreak

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.

Eurobread Inc. dba First Harvest
Boca Raton, FL

The FDA has issued a warning letter to Eurobread Inc., doing business as First Harvest, located in Boca Raton, FL, for significant violations of the Foreign Supplier Verification Program (FSVP). The violations, identified during an inspection from Feb. 2 to 7, 2025, are linked to a multistate and binational Salmonella Enteritidis outbreak involving Mini Patisseries from a foreign supplier. 

The FDA’s findings raise concerns about the safety of imported foods entering the U.S. market.

Inspection findings
The FDA’s inspection of Eurobread Inc., located at 1200 S Rogers Circle, Boca Raton, FL, revealed that the company failed to comply with FSVP regulations. These regulations require importers to verify that imported foods meet U.S. safety standards, equivalent to domestic requirements.

The inspection was prompted by a Salmonella Enteritidis outbreak linked to (Redacted by FDA)-brand Mini Patisseries manufactured by a foreign supplier, (Redacted by FDA) of (Redacted by FDA). The outbreak led to a Class 1 recall initiated on Jan. 17, 2025, following an investigation by the Canadian Food Inspection Agency (CFIA). The FDA placed the supplier’s Mini Patisserie ready-to-eat (RTE) pastries on Import Alert #99-19 on March 14, 2025, for Salmonella contamination, and all RTE foods from the supplier on Import Alert #99-43 on April 4, 2025, for insanitary conditions.

Critical violations

1. Failure to evaluate foreign supplier performance: Eurobread Inc. did not evaluate the performance of its foreign suppliers or the risks posed by their foods, as required. Specifically, the company failed to document its approval of suppliers for Mini Patisseries and another product, (Redacted by FDA), from suppliers in (Redacted by FDA). Records provided during the inspection, including a Safety Food Certificate and third-party audit certificates, did not demonstrate compliance with U.S. food safety regulations.
2. Lack of supplier verification activities: The company did not perform or document appropriate supplier verification activities, such as determining the frequency of verification or ensuring third-party audits considered FDA regulations, as required. While Eurobread Inc. obtained some documents, such as a Safety Food Certificate and audit certificates, these did not address applicable FDA standards, and the company failed to review or assess them promptly.

Company response
Eurobread Inc. responded to the FDA on Feb. 28, 2025, through a consultant, stating it would retain a Qualified Individual to implement its FSVP and stop importing from the supplier linked to the outbreak, which is reportedly no longer in business. The response included procedures for evaluating suppliers and reviewing third-party audits. However, the FDA found the response inadequate, as it lacked documentation of supplier reevaluation or compliance with U.S. preventive controls requirements.

FDA’s concerns and next steps
The FDA emphasized that Eurobread Inc.’s failure to comply with FSVP regulations could allow unsafe food to enter the U.S. market, as evidenced by the Salmonella outbreak linked to Mini Patisseries. The agency warned that continued noncompliance may lead to refusal of admission for implicated products, detention without physical examination under Import Alert #99-41, or other regulatory actions. Importing food without a compliant FSVP is a prohibited act under federal law.

Eurobread Inc. had 15 working days from receipt of the warning letter, dated July 31, 2025, to respond with specific corrective actions and supporting documentation. The FDA will assess the adequacy of these actions in future inspections.

The full warning letter can be viewed here.

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