FDA Visits Mead Johnson Facility In Formula Investigation

This week, the U.S. Food and Drug Administration (FDA) paid a visit to Mead Johnson as part of its investigation into potentially contaminated Enfamil baby formula. Mead Johnson Nutrition Company runs the Enfamil baby formula factory being investigated as part of a probe into the illness of one baby and the death of another.

As we’ve written, Mead Johnson, the maker of Enfamil Newborn Powder formula, said samples of the product it tested were negative for a bacterium that killed a 10-day-old Missouri infant earlier this month. We previously wrote that Wal-Mart Stores Inc., Walgreen Co., Kroger Co., and Safeway Inc. all pulled a batch of Enfamil Newborn powder formula from their shelves, pending an investigation into the baby’s death.

The child, Avery Cornett, died on December 18 after being removed from life support. Preliminary tests indicated Avery was suffering was Cronobacter sakazakii, a rare bacterial infection. Cronobacter is a microbe that can lead to permanent neurological damage, said Bloomberg Businessweek.

Avery’s parents were feeding Avery Enfamil Newborn powder purchased at a Lebanon, Missouri Wal-Mart. Illnesses from Cronobacter sakazakii are extremely dangerous to babies less than one month old and those born prematurely. The baby who fell ill was exposed to an array of formulas and other over-the-counter products, said the FDA.

Cronobacter sakazakii can be found in dried milk and powdered formula as well as naturally in the environment and in plants such as wheat and rice. Mead Johnson Nutrition had said its records showed the lot of Enfamil powder tested negative for the bacterium before it was shipped to stores.

The FDA visit this week is typical in investigations into bacterial infections, according to a company spokesman, said Reuters. Initial results are expected as early as this week; however, complete investigation results could take several weeks, said health officials. Two Mead Johnson tests indicated no sign of the Cronobacter bacterium.

“Because Cronobacter is so commonly present throughout the environment, we expect they are looking at a large number of other possible sources—water, clothing, bedding, preparation and use surfaces,” said Mead Johnson spokesman Chris Perille, wrote Reuters. “This is standard operating procedure for them, and we would expect that they have also had inspectors visit production facilities for various other products/items they are testing as part of this investigation,” Perille added.

The investigation, conducted by the FDA and the U.S. Centers for Disease Control and Prevention (CDC) included testing baby formula samples, distilled water, and the environment to which both babies were exposed, explained Reuters.

“We do not have evidence showing that the two infections are related, and the two cases occurring in the last month may represent nothing more than a coincidence,” CDC spokeswoman Kate Levinson Reuters via email.

Another baby who lives in Oklahoma and who is less than one month old was confirmed as falling ill with a Cronobacter infection this week. The baby, who was not exposed to Enfamil, is recovering after treatment, according to Reuters.