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]
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Earlier this morning, I emailed the last edition of my FDA-biweekly newsletter, Adverse Event Reporting News -- for the final time, and announced on page one that I will be shutting down my business, Washington Information Source Co., which I founded in 1991. It's been a real struggle even publishing one newsletter. I amalgamated my other 3 titles in 2019-2020 due to a dwindling subscriber base. It was a great business for 30 years, enabling me to save for retirement, save for my kids education and giving me the free time to pursue civic activities. The Web and social media have killed trade newsletters as they have newspapers. Here is the first 2 pages of AER with my "Farewell"
One of my old editors, passed away. Great guy
The coronavirus has finally forced Washington officials to try to get more of our drug and device production on shore due to shortages caused by the Chinese. But as a publisher of FDA newsletters for nearly 30 years, I have long known about the U.S. overreliance on China, India and their substandard quality standards and submitted a letter to the Wall Street Journal on the subject (click below to read it) and praising President Trump for pushing drug companies to bring their manufacturing to U.S. shores again. That photo is a former Johnson & Johnson facility in North Brunswick, NJ, which is now a massive shopping mall. A number of U.S. drug and device facilities moved offshore the last 20 years.http://thebullelephant.com/trumps-2017-call-to-make-american-drug-device-manufacturing-great-again/
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You are looking at 3 journalists (me on the left) who have covered the FDA the longest among the Washington trade press. Jill Wechsler, with Pharmaceutical Executive, who has been with them since 1990, and Bill Paulson, IPQ Publications, who started with the Gold Sheet in the early 1980s. I began covering FDA in 1986 for the Washington Drug Letter and Devices & Diagnostics Letter and started Washington Information Source in 1991. Perhaps the "Dean" of the FDA trade press now is Jim Dickinson of FDA Web View. He started with the Green Sheet in the mid 70s and launched his newsletters in 1982, but he was not at the meeting today. Photo taken at today's Food & Drug Law Institute annual meeting in Washington
The proposed Trump FDA budget calls for a doubling of user fees, meaning, the agency would not be funded much from general tax revenue. This is not allowed under the current user fee law, which is up for renewal in September. So, it seems the president would have to get congressional and drug, device, biologics and food industry concurrence to do this. In addition, there would be criticism about potential pressure on FDA in compliance and enforcement if industry is paying the bills for that. Read about it in this week's GMP/Supply Chain Report. For a free copy, email us at [email protected]