(CNN) 鈥� Lead-contaminated cinnamon applesauce pouches that may have sickened hundreds of children in the United States were not tested for heavy metals during their manufacture at an Austrofood facility in Ecuador, according to an inspection report from the US Food and Drug Administration.
The inspection, conducted at the facility in December, found that the plant 鈥渄id not sample and test the raw material or the finished product for heavy metals鈥� and did not have 鈥渁dequate sanitary facilities and accommodations,鈥� among other observations, according to an that was first through a Freedom of Information Act request and posted online Wednesday.
The document also notes that certain pasteurization steps were not adequately followed.
As of Friday, at least 385 reported cases of illness 鈥� of which 97 are confirmed, 253 probable and 35 suspected 鈥� have been linked to the fruit puree products across 42 states, according to the . Many of the cases have been in young children.
Reports of children with elevated blood lead levels, indicating potential acute lead toxicity, that was associated with cinnamon applesauce products sold in the United States under the brands WanaBana, Weis and Schnucks.
In November, manufacturer Austrofood and Wanabana USA, distributor of WanaBana products in the United States, said in a statement that the cinnamon in the products was the source of the elevated lead levels.
Wanabana recalled its apple cinnamon fruit puree pouches. Cinnamon applesauce pouches from the other brands, Schnucks and Weis, are also subject to recall.
In a , Wanabana USA announced that it has been collaborating with the FDA in managing the recall and continues to oversee the recall of all of its affected products from the market 鈥渋n close coordination with FDA.鈥�
The latest FDA inspection document noted that in September, the Austrofood facility conducted a hazard analysis for all raw materials and ingredients, including ground cinnamon. 鈥淗owever, cinnamon was not considered a significant hazard requiring a preventive control for heavy metals including lead,鈥� according to the document.
鈥淚n 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 high level of lead in finished products distributed by Wanabana,鈥� the document says. 鈥淔DA also conducted two sample collections of the ground cinnamon powder at Austrofood on December 05, 2023, and those samples also identified lead in the ground cinnamon.鈥�
This month, the FDA announced that while testing recalled products and cinnamon collected from the Austrofood facility, it found elevated levels of chromium as well as lead.
鈥淧eople who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed,鈥� the FDA said.
The health effects of chromium in this case are 鈥渄ifficult to predict,鈥� according to the CDC. Yet 鈥渨e know that there is no safe level of lead. CDC recommends discarding all affected products and not eating any of them. Anyone who may have eaten the affected products should talk with their healthcare provider.鈥�
can cause developmental delays in children, as well as head, stomach and muscle aches, vomiting, anemia, irritability, fatigue and weight loss.
An FDA official in December that the lead contamination in cinnamon applesauce pouches may have been an 鈥渋ntentional act.鈥�
Jim Jones, the FDA鈥檚 deputy commissioner for human foods, said in that interview that the agency is still investigating the lead-tainted cinnamon applesauce pouches, 鈥渂ut so far all of the signals we鈥檙e getting lead to an intentional act on the part of someone in the supply chain and we鈥檙e trying to sort of figure that out.鈥�
Contaminated spices are 鈥渋ncredibly common,鈥� Dr. Diane Calello, executive and聽medical聽director of the New Jersey Poison Control Center, . Some contamination occurs in natural products, including rice and apples, because they鈥檙e grown in soil that contains metals.
鈥淏ut then we do sometimes see intentionally contaminated products that are sold by weight. And the best way to make something heavy is to put metal in it, right?鈥� she said. 鈥淪o that鈥檚 why I think we frequently hear, maybe on the order of once or twice a month, about a product聽鈥撀爁or some reason, it鈥檚 often turmeric聽鈥撀燽ut a spice that鈥檚 contaminated with lead.鈥�
Calello emphasized the importance of聽聽for children at 1 and 2 years of age at their pediatricians鈥� office, noting that because of the pandemic some routines may have fallen behind.
In , Austrofood and Wanabana USA said that they have established a program to reimburse consumers of the recalled products who may have documented out-of-pocket costs for health care provider visits and blood testing up to a total amount of $150 for a lead test.
CNN鈥檚 Meg Tirrell and Jamie Gumbrecht contributed to this report.
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