Manufacturing Problems That Led To Similac Formula Recall Highlighted in FDA Inspection Report

FDA inspectors found Abbott failed to determine if complaints involving problems with infant formula products were linked to manufacturing issues that posed a larger health threat.

A recent federal inspection report details numerous sanitary failures and manufacturing problems prior to a Similac recall issued earlier this year, which has already been linked to hundreds of reports involving babies suffering Salmonella and other infections after being fed contaminated formula.

The FDA released its inspection report for the Abbott Laboratories infant formula manufacturing plant in Sturgis, Michigan late last month, outlining problems at the facility where all of the recalled infant formula was produced.

The investigators detected the presence of Cronobacter sakazakii on surfaces throughout the plant, and outline how Abbott failed to adequately follow up on consumer complaints involving problems with Similac and other infant formula products made by the company.

The report also details failings of sanitary procedures used by workers in the facility, which may be part of the root cause of the issues.

Similac, Alimentum and Elecare Recall

On February 17, Abbott Laboratories issued a massive baby formula recall impacting certain versions of Similac, Alimentum and EleCare, after acknowledging that products may contain Salmonella Newport and Cronobacter sakazakii bacteria.

Within days, reports began to surface that suggested the company knew about the Similac contamination problems at its facility since at least September 2021, when the Minnesota Department of Health began investigating a case involving an infant infected with Cronobacter. Two U.S. Senators have already launched an inquiry, asking why Abbott delayed issuing a recall or warning parents, and a number of Similac recall lawsuits have already been filed by parents of babies who suffered injuries.

The FDA indicates at least four infants were hospitalized and two died as a result of infant formula contamination linked to the recall, but the true number of illnesses caused by the recalled Similac, Alimentum and EleCare formulas is certainly much larger.

An overview of the FDA inspection report was detailed by the agency in a March 31 update to consumers about the status of the recall, but the full findings of the report have now been released.

“You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” FDA inspectors told the manufacturer.

In addition to four locations throughout the facility where Cronobacter was detected, inspectors also found standing water dripping from valves onto the facility floor. They also found some product dryers still in use at the facility had a history of problems dating back to 2018, and that investigations of complaints filed before the recall failed to make a determination of whether the complaints represented a health hazard.

Investigators also saw employees failing to use the necessary protective gear while working with raw materials, packaging, equipment and utensil contact surfaces.

Abbott Accused of Placing Profits Before Safety of Babies

Prior to the recall and disclosure of quality control problems at it’s Michigan manufacturing facility, Abbott Laboratories was already facing a number of Similac lawsuits brought by families of premature infants diagnosed with necrotizing enterocolitis (NEC) after being fed the cow’s milk-based formula, which alleged that the company placed its desire for profits before the safety of babies by failing to warn parents and medical providers about the risks their formula may pose for premature infants.

Necrotizing enterocolitis is a devastating disease that mostly impacts premature infants after being fed cow’s milk formula like Similac or Enfamil, where the wall of the intestine is invaded by bacteria, leading to destruction of the bowel and often requiring emergency surgery while the baby is still in the neonatal intensive care unit (NICU).

According to allegations raised in the baby formula NEC lawsuits, Abbott Laboratories has known about the increased risk of this condition among premature infants fed Similac instead of breast milk or donor milk, yet continued to market and promote its products for use among these vulnerable babies, even introducing versions of Similac specifically marketed for preemies.

Last week, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments on a motion filed by Abbott to centralize and consolidate all lawsuits filed against Abbott and Mead Johnson, the manufacturer of Enfamily, before one federal judge for coordinated discovery and pretrial proceedings. Their decision is still pending.