President Joe Biden meets virtually Wednesday with administration officials and major infant formula manufacturers to discuss efforts to accelerate infant formula production and ramp up imports of formula through Operation Fly Formula, at the White House in Washington, D.C. Photo by Bonnie Cash/UPI | License Photo
June 4 (UPI) -- Abbott Nutrition's Michigan plant reopened Saturday after its closure for months and a recall over contamination issues sparked a nationwide baby formula shortage.
The company said in a statement it was resuming production at the Sturgis, Mich., facility "after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16."
The Sturgis factory produced most of the country's supply of powdered Similac and specialty formulas, according to The Washington Post, which severely affected infant formula supply.
Abbott plans to resume production of EleCare and other specialty and metabolic formulas to release to consumers by about June 20, and is also working hard to resume production of Similac and other formulas, according to its statement.
"We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America," the company statement said.
"We will ramp production as quickly as we can while meeting all requirements. We're committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health providers have placed in us for 130 years."
The FDA inspected the plant in February after receiving complaints that two babies fell ill and were hospitalized, including one in Minnesota, and one in Texas, and two other babies in Ohio were hospitalized and died after consuming formula from the Sturgis facility that was contaminated.
Abbott told the Washington Post there is no clear evidence the contamination came from its factory.
Cronobacter bacteria were the source of the four infant infections, according to the Centers for Disease Control and Prevention and FDA investigations. Officials said that formula could become contaminated in the plant, in a home or elsewhere after a container is opened.
The FDA confirmed the presence of Cronobacter (sakazakii) bacteria in two finished Similac products, one in September 2019, and one in June 2020, and in five environmental samples collected during inspection of areas of powdered infant formula production, according to an inspection report from March of this year.
The report noted a lack of measures to prevent contamination of the infant formula.
Some other issues in the report included water leaks, moisture and condensation in dry powdered infant formula production areas, and an unnamed employee passing by a shoe spray station and failing to spray the soles of their shoes.
The inspection followed another report back in September, where the FDA found Abbott's Sturgis plant "did not maintain a building used in the manufacture, processing, packing or holding of infant formula in clean and sanitary condition."
"While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers," Abbott said in a statement in March.
"Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases. This follows the FDA's removal of the Salmonella case from its investigation earlier this month."