Abbott Baby Formula Whistleblower Complaint First Filed February 2021

NORTH CHICAGO, IL — Officials at Abbott Laboratories were notified about concerns of contamination at its Sturgis, Michigan, baby formula plant a year before an inspection by federal food safety regulators led to its shutdown, according to a new report.

The same employee who filed a whistleblower complaint with the Food and Drug Administration about the plant in October 2021 also filed earlier complaints with the state and federal Occupational Health and Safety Administrations, or OSHA, the Wall Street Journal reported this week.

The employee was terminated in August 2020 and first filed a discrimination complaint with the Michigan OSHA before submitting a complaint to the federal OSHA in February 2021. The complaint contained allegations about faulty equipment and the release of potentially unsafe formula, according to the Journal.

A spokesperson for Abbott told the Journal that company officials had investigated the federal complaint and were unable to confirm its allegations.

The former employee's federal OSHA complaint, according to company representatives, "continued a pattern of ever-evolving, ever-escalating allegations" that followed the employee's dismissal for "serious violations of food safety policies."

FDA records reviewed by the Journal show that federal regulators found Cronobacter sakazakii at the Sturgis plant during a September 2019 inspection. They subsequently notified Abbott officials that its employees were failing to test a batch of Similac formula for salmonella as much as the company's policies mandated.

The next year's inspection was put on hold due to COVID-19, but records show that when FDA inspectors returned to the plant in September 2021, they issued another notice that the company was failing to maintain the building in a "clean and sanitary condition," the Journal reported.

According to the FDA's timeline of events, inspectors sought to schedule a check of the Sturgis plant late after interviewing the whistleblower in December 2021 but decided to delay the inspection due to a reported COVID-19 outbreak at the facility.

Following reports of illnesses among infants who had consumed formula from the factory, FDA conducted an inspection despite the ongoing outbreak. What they found, according to FDA Commissioner Dr. Robert Califf, was "shocking."

The pause in production at the plant, which produces about a fifth of all U.S. powdered baby formula, contributed to a nationwide shortage of the product, 98 percent of which is produced domestically due to high import taxes.

Related:

• Abbott Restarts Baby Formula Production At Michigan Plant
• FDA Chief Testifies About Abbott Labs Recall, Unsanitary Conditions
• House Speaker Says Indictment May Be Needed Over Baby Formula Shortage