STURGIS, Mich. — Abbott Laboratories was alerted to allegations concerning problems at an infant-formula plant months earlier than previously publicly known, according to a government official, a person familiar with the matter and documents viewed by the Wall Street Journal.
A complaint filed under the U.S. Labor Department’s Occupational Safety and Health Administration’s whistleblower-protection program by a former Abbott employee in February 2021 alleged a host of problems at the company’s Sturgis plant. They included failing equipment in need of repair and formula released without adequate evidence that it was safe for consumption, the person familiar with the matter said.
Details of the complaint offer a fuller picture of the timeline leading up to the shutdown in February 2022 of Abbott’s plant in Sturgis, which has contributed to a severe U.S. baby-formula shortage. Abbott and the U.S. Food and Drug Administration already have come under fire in recent months for what lawmakers said was a slow response to problems in Sturgis, including allegations made in a subsequent complaint by the same person sent to the FDA in October 2021.
See: Baby-food sales surge amid the baby-formula shortage, as more parents consider transitioning babies out of the milk phase sooner
Also: Why there’s a shortage of baby formula — and why health experts say it’s dangerous to make your own formula
Labor Department officials provided the February 2021 complaint to Abbott as well as to the FDA that same month, according to the government official. Abbott submitted a formal response to the complaint two months later, according to the documents and the person familiar with the matter.
A spokesman for Abbott
said: “We investigated the federal OSHA complaint and have not been able to confirm the allegations.”
An expanded version of this report appears at WSJ.com.
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