The “unsanitary conditions” that led to the closure of a baby formula plant in February, which helped fuel a widespread formula shortage, were detailed to Congress on Wednesday.
A list of problems at the Abbott Nutrition plant in Sturgis, Michigan, included a leaking roof, standing water, cracks in equipment enabling bacterial growth, and a previous citation for inadequate handwashing, Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel.
“There is no dispute that the facility was unacceptably insanitary as evidenced by the consent decree,” Califf said. “Frankly, the inspection results were shocking.”
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The FDA has worked with Justice Department officials to dictate what steps the company needed to take to reopen, which is expected to be June 4, an Abbott spokesman told the New York Times.
Abbott is “committed to ensuring that this never happens again” and is verifying that every step is in place to ensure the quality checks are working throughout the 700,000-square-foot facility, Christopher Calamari, Abbott Nutrition’s senior vice president, said to the House panel.
A report from an anonymous whistleblower who said he worked at the baby formula plant was brought up repeatedly during the hearing. The whistleblower alleged that safety staff there “celebrated” the FDA overlooking problems after a 2019 inspection and did not destroy enough product when it found harmful bacteria in finished products, according to the report.
The closure of the Abbott plant in February was coupled with pandemic-related supply chain problems. The plant produces roughly one-fourth of the nation’s infant formula.
The FDA discovered numerous problems at the plant in the fall of 2021, coinciding with reports of babies being hospitalized with a rare bacterial infection. Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant, leading to a recall of the formula and a shutdown of the plant, according to the Centers for Disease Control and Prevention.
The White House has attempted to address the baby formula shortage with Operation Fly Formula, with the first flight containing 78,000 pounds of baby formula from Germany landing in Indiana on Sunday. However, none of it will go to stores right away, instead being distributed to hospitals, doctor’s offices, healthcare facilities, and pharmacies in areas where “needs are most acute,” a Biden administration official told CNN on Monday.
Nestle offered to fly extra baby formula to the United States on May 17, with priority given to two brands, Gerber Good Start Extensive HA and Alfamino, which are designed for babies with allergies to cow’s milk protein.
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Doctors have warned parents not to make their own baby formula and not to purchase products the FDA has not approved from other countries.
