FDA WARNING_LETTER - Agroson's LLC - August 12, 2019

The FDA issued a Warning Letter to Agroson’s LLC following a Foreign Supplier Verification Program (FSVP) inspection on August 12, 2019, and in response to a pattern of importing adulterated papayas. The letter details the firm's involvement in multiple multistate Salmonella outbreaks linked to whole, fresh papayas in 2017 and 2019, and instances where imported papayas tested positive for Salmonella in 2011 and 2017.

Specifically, in 2019, Agroson’s LLC imported Cavi brand papayas implicated in a Salmonella Uganda outbreak affecting 71 people in 8 states. The firm refused to initiate a voluntary recall, prompting the FDA to issue a public notice and contact wholesale customers. In 2017, the firm imported papayas from Carica de Campeche, linked to a multi-state Salmonella outbreak (251 cases, 2 deaths). Additionally, a 2017 shipment from El Zapotanito tested positive for Salmonella Urbana, matching clinical isolates from an outbreak cluster. In 2011, two shipments imported by Agroson’s LLC tested positive for Salmonella.

These actions constitute a pattern of importing or offering for import adulterated food that presented a threat of serious adverse health consequences or death, violating Section 301(a) of the FD&C Act [21 U.S.