After a recent inspection, the FDA has determined that the Ecuadorian company Austrofood S.A.S never tested its apple sauce pouches for heavy metals including lead. The negligent oversight has led to at least 385 lead poisoning cases in the United States.
Austrofood is the company behind the WanaBana brand cinnamon applesauce, as well as batches from store brands Weis and Schnucks that were also recalled, which the Centers for Disease Control and Prevention now says has been linked by state and local health authorities to at least 385 cases of lead poisonings across the U.S.
Many cases have been in very young children, who are especially vulnerable to the long-lasting developmental delays caused by lead poisoning, the CDC has said.
At least 42 states have reported lead poisoning connected to the apple sauce pouches.
The FDA says the company failed twice, when analyzing the process for producing its applesauce products, to draw up plans to mitigate the risk that the cinnamon it was buying might end up contaminating its products.
“In addition, you did not sample and test the raw material or the finished product for heavy metals. Furthermore, sampling conducted by FDA in the United States identified [a] high level of lead in finished products,” the agency’s inspectors said.
Other issues the FDA found at the plant included shortfalls in its pasteurization and sanitation procedures. Austrofood was also cited for “numerous rough edges, chipped, and pitted areas” on one of its equipment that could break loose and end up in its products.
The FDA previously inspected the plant once before in 2019, FDA records show, which at the time did not result in any citations to the company.