Officials from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) inspected the facility following the death of a 10-day-old infant in the state of Missouri before Christmas who was said to have eaten infant formula produced by the company.
The incident led to Walmart withdrawing a batch of Mead Johnson’s Enfamil PREMIUM(R) Newborn, product from 3,000 of its stores across the US.
But federal inspectors last Thursday gave the company’s facility the all-clear after announcing that samples tested at the site were found negative for Cronobacter.
The agencies said there was “currently no evidence to conclude that the infant formula….was contaminated during manufacturing or shipping”.
The bodies said they were awaiting the results from further analyses.
No recall necessary
Authorities also ruled out the need to recall the powdered baby product.
“Based on test results to date, there is no need for a recall of infant formula and parents may continue to use powdered infant formula, following the manufacturer’s directions on the printed label,” said the FDA and CDC in a joint statement.
A Mead Johnson statement said the results were “consistent with two rounds of testing conducted” by the company.
"We're pleased with the FDA and CDC testing, which should reassure consumers, healthcare professionals and retailers everywhere about the safety and quality of our products. These tests also reinforce the rigor of our quality processes throughout our operations," said Tim Brown, senior vice president and general manager for North America.
The firm said that all its infant formulas undergo approximately 2,300 quality checks and safety tests before being made available to consumers to ensure they meet both national and international standards.
The FDA/CDC investigation was launched after four cases of Cronobacter were detected in Florida, Illinois, Missouri, and Oklahoma. But the agencies said at least two of the cases were not related as the bacteria differed genetically. Bacteria from cases in Oklahoma and Florida were not available for analysis, it said.
Cronobacter is a very rare cause of a severe infection in young infants, and usually occurs in the first days or weeks of life. It causes severe bacterial sepsis or meningitis in infants, which often starts with fever, and usually includes poor feeding, crying or listlessness. Typically the US has about 4-6 cases annually although recently increased awareness meant 12 cases were reported in 2011, said the CDC.