FDA Sends First Warning Letter to Importer for FSVP Violations
The Food and Drug Administration recently sent its first warning letter to an importer for violations of Foreign Supplier Verification Program requirements, FDA said in a press release. In a letter dated July 30, FDA told Florida-based Brodt Zenatti Holdings that it may get put on new Import Alert 99-41 and have its shipments refused at the border if it doesn’t demonstrate soon to the agency that it has put in place an FSVP program for the food it imports.
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According to the letter, FDA inspected Brodt Zenatti as part of an investigation into a multi-state salmonella outbreak that identified Karawan-brand tahini as the likely source. Brodt Zenatti imported Karawan tahini. The inspection found that Brodt Zenatti had not developed an FSVP plan for the Karawan tahini.
“We acknowledge you have conducted a voluntary recall of Karawan brand and SoCo brand of tahini, and you verbally committed to cease importing the product,” FDA said in the warning letter. “However, to date, we have not received your response to the” FDA form identifying the FSVP violations, “and your voluntary recall does not address your FSVP violations,” the agency said.
FDA told Brodt Zenatti to respond within 15 days of the letter with documentation of the actions the importer is taking to address the FSVP violations, “such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation.”
FDA threatened to put Brodt Zenatti on its new import alert for FSVP, 99-41, if it doesn’t “take prompt action” to correct the violations. “Karawan brand tahini is currently subject to [Detention Without Physical Examination (DWPE)] per import alert 99-19, as a consequence of being found contaminated with Salmonella,” FDA said.
“Since 2017, the FDA has been conducting FSVP inspections, with a primary focus on helping importers understand the requirements and how to take corrective actions if deficiencies are observed. Moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk,” FDA said in its press release.
“Import Alert #99-41 is an important part of our continued implementation of the FSVP regulation and may apply to any importer in violation of FSVP. In this case, the foreign supplier of the tahini involved in the outbreak is subject to a separate import alert.”