Manufacturer Failed to Properly Test Product:
The U.S. Food and Drug Administration (FDA) conducted an inspection of Austrofoods S.A.S. between December 4th and 14th of 2023, in the wake of the WanaBana Cinnamon Applesauce lead contamination notice issued by FDA in November. The FDA echoed a recall of WanaBana, Schnuck’s-brand, and Weis-brand applesauce pouches with cinnamon, including variety packs and three-packs following testing that showed extremely high levels of lead poisoning. The company, WanaBana, issued its initial recall on November 9, 2023. According to the company, ” WanaBana USA is voluntarily recalling all lots of WanaBana Apple Cinnamon Fruit Purée pouches due to reports of elevated levels of lead found in certain units of the product.”
Since that time, many young children have been identified as having extremely high levels of lead in their blood after consuming the now-recalled product.
The FDA inspection resulted in a 483 Report which made the following findings (among others):
- Austrofoods did not identify a hazard that required preventative control:
- Austrofoods conducted a hazard analysis on November 14, 2022, for all incoming raw materials, but did not identify any raw materials requiring a preventive control;
- Austrofoods failed to identify Cinnamon as a raw ingredient;
- Austrofoods conducted another hazard analysis, on September 27, 2023, for all raw materials ingredients, including ground cinnamon. However, cinnamon was not considered a significant hazard requiring a preventive control for heavy metals including lead;
- Austrofoods failed to sample and test the raw material or the finished product for heavy metals;
- Austrofoods failed to properly comply with critical steps in ensuring proper pasteurization;
- Austrofood’s Food Safety Plan for “Fruit and Vegetable Pulp, Purees, and Compotes in Pouches MASC-004-C” did not identify the preventive control point that is necessary to control a physical hazard;
- Austrofoods allowed numerous rough edges, chipped, and pitted areas on some stainless-steel equipment that could lead to dangerous outcomes; and
- Austrofoods did not have adequate sanitary facilities and accommodations, such as not having proper backflow protection to prevent or avert potentially dangerous back siphonage.
According to one national food safety attorney, Ron Simon, who has focused on food safety for two decades, “the lead should never have made it this far in the food preparation process. Safety steps are supposed to be built into proper food manufacturing to screen for heavy metals, to test raw ingredients, and to perform safety tests on products prior to shipping them to retailers. The manufacturers of this product, the WanaBana Cinnamon Applesauce pouches, failed to perform these steps to the great detriment of the children in the U.S.” Simon represents dozens of the victims and is one of the attorneys to have filed suit against the manufacturers.
The inspection was performed at Austrafoods S.A.S. in Quito, Pichincha, 171104 Ecuador. The 483 Report was issued to Francisco Pena, Austrofoods’ president, A copy of the inspection report is available.
