05/19/2022
FDA allowed infant formula on market in 2012 despite presence of Cronobacter in MJ plant, 4 deaths; went harder on Abbott triggering current shortage
Twice as many inspectors sent to Abbott plant than Mead Johnson facility in 2012
By Ken Reid
Editor, Inspection Monitor
The U.S. Food and Drug Administration, which triggered a widespread shortage of infant formula due to its adverse inspection of an Abbott Labs plant in Michigan, leading to a recall and plant closing, treated a comparable facility by Mead Johnson in 2012 much lighter, despite the presence of the same bacteria in that plant and complaints about deaths and adverse reactions.
Records obtained by Food & Drug Inspection Monitor, a trade newsletter of Washington Information Source, Mclean, VA, show that Mead Johnson’s (MJ) facility in Evansville, IN, was inspected in January and February 2012, after FDA gave the facility a clean bill of health based on testing samples of Cronobacter.
According to the Establishment Inspection Report (EIR), FDA’s audit was spurred by 91 reports of infants having a series of adverse reactions to the company’s Enfamil formula, produced in powdered form like the formula Abbott was forced to recall in March.
According to an article in Food Navigator on Jan. 2 2012, there also were four infant deaths, two of which were said to be caused after the babies consumed the MJ formula.
The latest Abbott recall in March 2022, which has led to the baby formula shortage, and babies reported being malnourished, also was triggered by reports of infant deaths due to Cronobacter found at Abbott’s Sturgis, MI, plant. But the company maintains Cronobacter was not in the formula – just in the plant.
According to the Mead Johnson EIR, the audit was triggered by consumer complaints involving “infants who tested positive for Cronobacter Spp)m” which is a rare ailment that can afflict infants.
Findings from both inspections are similar, yet MJ’s case triggered no “official action” from the agency, nor a recall. In addition, MJ had only six FDA inspectors in the 2012 audit vs. 12 sent to Abbott’s Sturgic plant. Inspection Monitor Editor Ken Reid, who has covered FDA since 1986, said this “looks like a case of regulatory overkill.”
In fact, according to, Food Navigator, the agency gave MJ a clean bill of health BEFORE the FDA inspection even occurred.
Inspection Monitor got no responses from FDA spokesperson Jennifer Dooren when asked about why the two companies were treated so differently.
Copies of the Mead Johnson and Abbott Inspection records are available from editor Ken Reid at [email protected] 703 779 8777
