According to documents recently released by the FDA, the agency knew about ongoing cleanliness and contamination issues at the Sturgis, Michigan Abbott facility implicated in contaminated baby formula since at least autumn of 2019. Among the infractions found by federal inspectors during their visit to the plant that manufactures Similac, Alimentum, and EleCare formulas were failures to maintain clean surfaces within the plant that were used directly in the production of the formula product. The plant’s issues with cronobacter bacteria were widespread, with eight known instances of plant contamination between fall of 2019 and February of this current year.
The recalls ordered as a result of the Abbott facility’s failure to maintain environmental cleanliness have exacerbated an already strained national supply of infant formula. The Infant Nutrition Council of America recently warned that national stocks of infant formula are down 17% from where they were at the start of the COVID-19 pandemic. Abbott has refused to state exactly how many lots of its formula have been recalled throughout this most recent contamination crisis, but the affected brands are among the top selling and best known brands in the world. The company says that it is taking the situation “very seriously and working closely with the FDA to implement corrective actions.” Perhaps they can start with the basics like ensuring that their employees wash their hands before making food for infants.
While the corporation’s failure to maintain a clean environment while producing such a sensitive product is terrible, ire has also been focused on the Food and Drug Administration for their lack of response to the contamination as the crisis unfolded. Notifications of illnesses that could have been linked to bacterial contamination were received by the FDA as early as September of last year. And, even once they were received, the agency failed to dispatch inspectors to the Sturgis, Michigan plant for at least another four months. Federal officials wouldn’t issue a recall of Abbott formula for another three weeks after that. Parent groups and legislators are now asking why it took the agency responsible for ensuring the safety of the nation’s food and medical supplies nearly five months to react not only to a food-borne contamination event but one that involves the most vulnerable among us.