(CNN) — 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 “did not sample and test the raw material or the finished product for heavy metals” and did not have “adequate sanitary facilities and accommodations,” among other observations, according to an FDA document that was first obtained by CBS News 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 – of which 97 are confirmed, 253 probable and 35 suspected – have been linked to the fruit puree products across 42 states, according to the US Centers for Disease Control and Prevention. Many of the cases have been in young children.
Reports emerged in October 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 statement in December, 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 “in close coordination with FDA.”
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. “However, cinnamon was not considered a significant hazard requiring a preventive control for heavy metals including lead,” according to the document.
“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 high level of lead in finished products distributed by Wanabana,” the document says. “FDA 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.”
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.
“People 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,” the FDA said.
The health effects of chromium in this case are “difficult to predict,” according to the CDC. Yet “we 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.”
Lead exposure can cause developmental delays in children, as well as head, stomach and muscle aches, vomiting, anemia, irritability, fatigue and weight loss.
An FDA official told Politico in December that the lead contamination in cinnamon applesauce pouches may have been an “intentional act.”
Jim Jones, the FDA’s deputy commissioner for human foods, said in that interview that the agency is still investigating the lead-tainted cinnamon applesauce pouches, “but so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.”
Contaminated spices are “incredibly common,” Dr. Diane Calello, executive and medical director of the New Jersey Poison Control Center, said last month. Some contamination occurs in natural products, including rice and apples, because they’re grown in soil that contains metals.
“But 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?” she said. “So that’s why I think we frequently hear, maybe on the order of once or twice a month, about a product – for some reason, it’s often turmeric – but a spice that’s contaminated with lead.”
Calello emphasized the importance of regular lead screening for children at 1 and 2 years of age at their pediatricians’ office, noting that because of the pandemic some routines may have fallen behind.
In their statement last month, 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’s Meg Tirrell and Jamie Gumbrecht contributed to this report.
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