FDA cites Eurobread for import failures behind Salmonella outbreak
As part of its application activities, the Food and Drug Administration sends warning letters to the entities under its jurisdiction. Some letters are only displayed for the public before weeks or months after sending. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued as long as a company has had no months to correct the problems.
Eurobread Inc. DBA First harvest
Boca Raton, Fl
The FDA has issued a warning letter to Eurobred Inc., doing business like First Harvest, located in Boca Raton, FL, for significant violations of the Provider Providers Verification Program (FSVP). The violations, identified during an inspection from February 2 to 7, 2025, are linked to a multistate and binational epidemic of Salmonella Enteritidis involving mini-pastries of a foreign supplier.
The FDA results raise concerns about the safety of imported food entering the American market.
Inspection results
The Inspection by the FDA of Eurobred Inc., located at the 1200 S Rogers Circle, Boca Raton, FL, revealed that the company had not respected the FSVP regulations. These regulations require importers to verify that imported foods meet US security standards equivalent to interior requirements.
The inspection was caused by an epidemic of Salmonella Enteritidis linked to (FDA expurred) – Mini mini pastries manufactured by a foreign supplier, (FDA expurred) of (FDA expurred). The epidemic led to a class 1 reminder initiated on January 17, 2025, following a survey by the Canadian Food Inspection Agency (CFIA). The FDA placed ready-to-eat pastries (RTE) of the supplier of the supplier on alert # 99-19 of March 14, 2025, for contamination by Salmonella, and all the supplier RTE food on an alert import # 99-43 on April 4, 2025, for insanitary conditions.
Critical violations
- Performance evaluation of foreign suppliers: EuroBred Inc. did not evaluate the performance of its foreign suppliers or the risks posed by their food, as required. More specifically, the company has not documented its supplier approval for mini-pastries and another product (((FDA expurred), suppliers in (FDA expurred). The files provided during the inspection, including a certificate of safety food and third -party audit certificates, have not demonstrated compliance with American regulations on food security.
- Lack of supplier verification activities: The company has not carried out or documented the verification activities of the appropriate suppliers, such as the determination of the frequency of verification or the guarantee of third -party audits considered as regulations of the FDA, as required. While Eurobobread Inc. obtained certain documents, such as a safety certificate and audit certificates, they did not meet applicable FDA standards, and the company has not examined or evaluated quickly.
Business response
EuroBobred Inc. responded to the FDA on February 28, 2025, through a consultant, declaring that he would keep a qualified person to implement his FSVP and stop the importation of the supplier linked to the epidemic, which would no longer be in business. The answer included procedures to assess suppliers and examine third -party audits. However, the FDA found the inadequate response because it lacked documentation of the revaluation of suppliers or compliance with the requirements of American preventive controls.
The concerns of the FDA and the next steps
The FDA pointed out that the non-compliance with Eurobred Inc. to comply with the FSVP regulations could allow dangerous foods to penetrate the American market, as evidenced by the Salmonella epidemic linked to the mini-pains. The agency warned that continuous non-compliance could lead to refusal of admission to products involved, without physical examination under alert # 99-41 import or other regulatory actions. Importing food without compliant FSVP is a prohibited act under federal law.
EuroBread Inc. had 15 working days from the reception 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 complete warning letter can be viewed here.
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