The Food and Drug Administration (FDA) discovered that the manufacturer behind the applesauce products tied to an onslaught of lead poisoning cases did not test its products for heavy metals.
The finding is one of a handful of shortfalls the federal agency discovered during its inspection of the Ecuador-based Austrofood S.A.S. factory, which manufactured the recalled WanaBana, Schnucks or Weis-brand apple cinnamon pouches.
"You did not sample and test the raw material or the finished product for heavy metals," the FDA said in its notice.
The agency continued by saying that "sampling conducted by FDA in the United States identified high level of lead in finished products distributed by Wanabana" and that it had conducted two sample collections of the ground cinnamon powder at Austrofood in December, and "those samples also identified lead in the ground cinnamon."
NY HEALTH OFFICIALS CONFIRM LEAD CASE TIED TO APPLESAUCE RECALL
The FDA also observed that the manufacturer "did not identify a process preventive control for a hazard when one was needed." For instance, the FDA discovered that there are "numerous rough edges, chipped, and pitted areas" on its stainless-steel conveyor and that the metal pieces from the conveyor "can break loose and become a source of metal inclusion that could enter food during processing."
It also discovered that the factory did "not have adequate sanitary facilities and accommodations."
Lawmakers have already sounded the alarm over this recall as cases of lead poisoning continue to rack up around the country, including in children who are more susceptible to lead toxicity.
Lawmakers are demanding answers from the FDA about why it believes the lead contamination in the recalled applesauce pouches could have been intentional and the steps it has taken to investigate the matter as well as prevent future illicit food contamination in the supply chain.
As of January 22, the FDA has received a total of 90 confirmed complaints or reports of adverse events potentially linked to the pouches, which were initially recalled in November after four children were found to have elevated blood lead levels.
In its investigation, the FDA has said it was exploring the possibility that the high lead levels in the recalled products were the "result of economically motivated adulteration."
Officials believe that the cinnamon – supplied from Negasmart to Austrofoods – could be the source of the contamination.
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The people who reported becoming infected ranged in age between newborns and age 53.
The Centers for Disease Control and Prevention (CDC), which is also investigating the outbreak, received 385 reports of lead poisoning cases, 97 of which have been confirmed.
