Infant formula manufacturer Abbott Nutrition issued a massive voluntary nationwide recall in February 2022 that further exacerbated the already strained infant formula market in the United States. Abbott pulled three powdered formulas produced at its facility in Sturgis, Michigan, from shelves after reports of infant injuries and deaths linked to the bacteria, Cronobacter sakazakii. Now, an ABC investigative report discovered that other baby formula manufacturers have operational deficiencies similar to the ones that spurred the shutdown of Abbott’s infant formula plant. 

Ramifications of Abbott Nutrition’s Recall

Abbott Nutrition initiated the infant formula recall after four babies developed Cronobacter illnesses after ingesting the company’s formula. Following the warning issued to the public, the FDA investigated Abbott’s Sturgis, Michigan, manufacturing plant. Upon its investigation, the agency identified several positive Cronobacter results from environmental samples and stated that Abbott failed to adequately clean surfaces to avoid contamination. This recall and subsequent shutdown magnified the infant formula shortage, so other infant formula companies stepped in to increase production. Companies like Gerber and Mead Johnson boosted production to meet infant formula demands, but FDA documents reveal that these companies like Abbott have questionable manufacturing environments. 

ABC News Reviews Decades of FDA Inspections of Infant Formula Manufacturers

The FDA performs inspections of U.S. manufacturing facilities without warning to ensure companies are compliant with cleanliness and manufacturing standards. However, many of these routine visits have produced concerning results for companies that account for roughly 90% of the United States infant formula market.

In 2021, the FDA inspected a Mead Johnson facility in Indiana to find that the company did not sufficiently record its data to monitor the sterility of its product. Furthermore, the FDA discovered that the company’s records revealed Cronobacter was found in one of the plant’s rooms. Also, investigators noted unsanitary practices like operators not washing their hands or swapping out gloves. 

Before this visit, the FDA visited a Mead Johnson plant in New Zealand in 2017 after two batches of formula tested positive for Cronobacter. Upon further investigation, the agency uncovered that this facility found Cronobacter in critical areas of the processing environment on twenty-six separate occasions. Water seeping through the walls of the plant and equipment condensation may have contributed to the high instances of Cronobacter. 

Again in 2021, the FDA made a trip to Nestlé Nutrition’s facility in Wisconsin that produces Gerber baby food products. Investigators saw dirty scoops from days prior lying on a table in the raw materials room and also noticed debris littering the floor. Additionally, the agency detected Cronobacter in an in-process batch of infant formula. The contaminated batch was then immediately destroyed.  

Following a routine inspection in 2019, the FDA notified PBM Nutritionals, which makes formulas for Walmart and Amazon, of objectionable conditions at its Vermont plant. PBM Nutritionals submitted documents to the FDA that detailed a recent roof leak that affected the drainage system. The agency’s sample swabs tested positive for Cronobacter. 

More Testing Going Forward

Despite these alarming FDA findings in the last few years, Gerber, PBM, and Mead Johnson assert that producing quality formula while keeping babies safe is their top priority. In response to these investigations, the infant formula manufacturers claimed to have implemented corrective action plans and enhanced quality control processes. Yet, given the abundance and robustness of Cronobacter sakazakii in the environment, the FDA wonders if its current system is enough to monitor infant formula manufacturers. An FDA spokesperson stated that the agency is considering incorporating additional environmental sampling in its annual inspections of infant formula facilities. However, the agency walks a fine line with infant formula manufacturers. Although the FDA wants to ensure infants receive safe formula, the agency has expressed concerns over disrupting the supply chain due to the current state of infant formula in the United States.