Testimony from FDA Commissioner Reveals Unsanitary Conditions at Baby Formula Manufacturing Facility

During last week’s Congressional hearing before the House Subcommittee on Oversight and Investigations, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf highlighted the myriad problems that led to the shutdown of Abbott Nutrition’s infant formula manufacturing facility in Michigan earlier this year. Contamination of formula products with Salmonella and Cronobacter bacteria resulted in a massive recall of Similac, Alimentum, and EleCare baby formula produced at the facility and contributed to infant illnesses and hospitalizations across three states, including at least two infant deaths. If your child became ill allegedly as a result of a Salmonella Newport or Cronobacter sakazakii infection from exposure to Similac, Alimentum, or EleCare powdered baby formula produced at Abbott’s facility in Sturgis, Michigan, contact Consumer Safety Watch today to learn about your legal options.

Pathogens Found in Infant Formula at Manufacturing Plant

The unacceptable conditions at the manufacturing facility in Sturgis, Michigan highlighted by the FDA Commissioner are believed to have contributed to the outbreak of Salmonella and Cronobacter infections, which are rarer but can be deadly in infants. Cronobacter sakazakii is a germ that occurs naturally in the environment and can live in dry foods, such as powdered baby formula. In fact, the U.S. Centers for Disease Control and Prevention (CDC) warns on its website that “Cronobacter infections in infants less than 12 months old are often linked to powdered infant formula.” According to the FDA, four Cronobacter sakazakii infections, one Salmonella Newport infection, and at least two infant deaths have been reported in connection with contaminated Similac, Alimentum, and EleCare baby formula manufactured at the shuttered Abbott plant in Sturgis. All five illnesses resulted in hospitalization and Cronobacter infection may have contributed to the cause of death in both fatal cases.

The FDA Commissioner’s testimony came during a House Oversight and Investigations hearing, during which members of the U.S. House of Representatives Committee on Energy and Commerce discussed the implications of the nationwide formula shortage, which was exacerbated by the shutdown of Abbott’s manufacturing facility in Sturgis. It was during a routine inspection in September 2021 that the FDA first discovered issues at the facility, including standing water inside the plant and factory personnel working directly with formula without using proper hand hygiene. An on-site inspection and review of internal records revealed several positive Cronobacter sakazakii results from environmental samples from the factory, as well as evidence of environmental contamination with Cronobacter sakazakii and the company’s destruction of product due to the presence of Cronobacter bacteria. Califf also noted several quality control problems, including Abbott’s failure to follow up on complaints of illnesses, despite the potential risk these illnesses posed to infants.

Abbott Plant Accused of “Cutting Corners”

Abbott’s manufacturing facility in Sturgis, Michigan has been shut down since mid-February, when the Salmonella and Cronobacter contamination was first uncovered. However, Abbott and the FDA recently reached an agreement on the steps the company must take in order to resume manufacturing baby formula at the Sturgis facility, including properly sanitizing the facility and its equipment and hiring a qualified expert to oversee the facility’s sanitizing and manufacturing processes, among other improvements. “The impact from just one infant formula plant closing in the United States shows the power one single manufacturer has to influence the nation’s supply of formula when just three companies control roughly 95 percent of the market,” stated House Energy and Commerce Chairman Frank Pallone, Jr. in his opening statement at the hearing. “We are too reliant on too few companies to do the right thing – and when just one of those companies cuts corners, we spiral into an emergency.”

Find Out Whether You are Eligible to File a Claim

The planned reopening of the Sturgis manufacturing facility could help ease the strain the ongoing formula shortage has caused for families across the country who rely on formula to feed their young children. However, Salmonella Newport and Cronobacter sakazakii infections aren’t the only potential health risks parents of formula-fed babies must consider. There have been increasing reports of a potentially deadly intestinal disease called necrotizing enterocolitis (NEC) occurring among premature babies fed cow’s milk-based infant formula instead of breastmilk in the neonatal intensive care unit (NICU) or at home. Parents across the country whose babies suffered injuries or died from NEC have begun filing baby formula NEC lawsuits against the manufacturers of cow’s milk-based infant formulas and fortifiers who marketed their products as safe for premature babies. To learn whether you may qualify for compensation for any harm your child allegedly suffered from infant formula, contact Consumer Safety Watch today.