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Ryan Robertson

Anchor/Investigative Reporter

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U.S.

FDA, Abbott knew of baby formula problems earlier than admitted

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Ryan Robertson

Anchor/Investigative Reporter

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Abbott Nutrition and the Food and Drug Administration were alerted to problems with the production of baby formula in early 2021. The revelation contradicts testimony by Abbot and the FDA and places the written formula warning months earlier than both the company and agency previously admitted.

A former Abbott employee filed a complaint with OSHA at the U.S. Labor Department in February 2021, the Wall Street Journal reported. The Labor Department sent the complaint to both Abbott and the FDA later that month.

The complaint alleged a slew of problems at the company’s Sturgis facility, including failing equipment and formula sent to market without adequate testing.

Abbott responded to the complaint two months later. The FDA did not respond, according to the Journal.

Another complaint was filed in October 2021, by the same former employee, making similar allegations.

Abbott closed its Sturgis facility in February 2022 as a result.

During a congressional hearing in May, neither the FDA nor Abbott acknowledged the February 2021 complaint.

In fact, Abbott Senior Vice President for U.S. Nutrition Chris Calamari said the company didn’t learn about the complaint until it was made public by Congress in April 2022, according to ABC News.

FDA Commissioner Robert Califf and other officials told Congress that the first time the agency heard of the complaint was February 2022 and blamed “mailroom issues.” Politico reported that the complaint was mailed directly to then-acting Commissioner Janet Woodcock and others in October but “did not reach the FDA’s highest rungs until mid-February.”

ABBOTT AND THE FOOD AND DRUG ADMINISTRATION WERE ALERTED TO  PROBLEMS WITH THE PRODUCTION OF INFANT FORMULA MONTHS EARLIER THAN BOTH THE COMPANY AND AGENCY HAD PREVIOUSLY ADMITTED.

A COMPLAINT WAS FILED WITH OSHA IN FEBRUARY OF 2021 BY A FORMER ABBOTT EMPLOYEE. THE COMPLAINT WAS SENT TO BOTH ABBOTT AND THE FDA.

THE COMPLAINT ALLEGED A SLEW OF PROBLEMS AT THE COMPANY’S STURGIS FACILITY INCLUDING FAILING EQUIPMENT AND FORMULA SENT TO MARKET WITHOUT ADEQUATE TESTING.

ABBOTT RESPONDED TO THE COMPLAINT TWO MONTHS LATER.

ANOTHER COMPLAINT WAS FILED IN OCTOBER OF 2021, BY THE SAME FORMER EMPLOYEE, MAKING SIMILAR ALLEGATIONS.

ABBOTT CLOSED ITS STURGIS FACILITY IN FEBRUARY OF THIS YEAR AS A RESULT.

BUT DURING A CONGRESSIONAL HEARING LAST MONTH, NEITHER THE FDA NOR ABBOTT ACKNOWLEDGED THE FEBRUARY 2021 COMPLAINT.

IN FACT, ABBOTT’S V.P. OF U.S. NUTRITION SAID THE COMPANY DIDN’T LEARN ABOUT THE COMPLAINT UNTIL IT WAS MADE PUBLIC BY CONGRESS THIS APRIL.

THE FDA SAID THE FIRST TIME IT HEARD OF THE COMPLAINT WAS FEBRUARY OF 2022.