Abbott, FDA warned of problems at plant months earlier than previously known: report

Abbott Laboratories and the Food and Drug Administration (FDA) were notified about possible problems at an Abbott plant in Sturgis, Mich., that makes baby formula in February 2021, The Wall Street Journal reported Thursday.

The Journal’s reporting cites documents that the newspaper viewed, a person familiar with the matter and a government official. 

The revelation is potentially damaging in that it suggests officials knew about possible problems at the plant much earlier than previously known.

The Biden administration has faced criticism over the baby formula shortage, which has panicked parents across the country struggling to find formula for their young children.

President Biden has authorized the use of the Defense Production Act to help deal with the shortage, which has been blamed on supply chain issues and the Abbott shutdown.

According to the Journal’s report, a discrimination complaint was made to the Michigan Occupational Safety and Health Administration (OSHA) by a former employee at Abbott after the worker was fired in August 2020.

A separate complaint was made in February 2021 to federal OSHA followed by a third complaint sent to the FDA in October 2021, with a person familiar with the matter telling the newspaper that all three complaints were made by the same individual.

The Journal noted that Abbott and the FDA had received the February 2021 complaint, which was made through the whistleblower protection program at OSHA the same month it was filed.

The February 2021 complaint raised product safety concerns, alleging that formula was being distributed without proof that it could be consumed safely and that some equipment needed to be repaired, a person familiar with the matter told the Journal.

That person and documents viewed by the Journal indicate that two months after Abbott was made aware of the February 2021 complaint, it had issued a formal response on the matter.

A person close to the matter confirmed to The Hill that OSHA received a whistleblower complaint on Feb. 16, 2021, and then delivered it to FDA and Abbott on Feb. 19, 2021.

The FDA offered congressional testimony last month indicating it had received its first consumer complaint of Cronobacter from an infant in September 2021 and that it had notified Abbott a day later. The FDA has also acknowledged receiving a confidential complaint on the matter in October 2021, but its timeline does not disclose any complaints received in February of that year.

Previous testimony from Abbott does not include details on the February 2021 complaint.

“We know there have been various questions about the timeline of events leading up to the FDA’s warning and Abbott’s recall of products manufactured at their Sturgis facility,” the FDA said in a statement. “Our top priority right now is addressing the dire need for infant formula in the U.S. market, and our teams are working night and day to help make that happen – including ensuring Abbott takes the appropriate corrective action to address insanitary conditions observed by the FDA.”

Abbott said in a statement that the February 2021 complaint “raised new and different topics” than the one filed in 2020, which the company said had been dismissed.

“It continued a pattern of ever-evolving, ever-escalating allegations. We investigated the federal OSHA complaint and have not been able to confirm the allegations,” Abbott said of the February 2021 complaint.

Abbott’s Sturgis plant closed earlier this year after four babies who had formula from the plant contracted the rare Cronobacter bacterial illness.

Abbott has claimed that the genetic sequencing of samples of several infants who became sick do not match samples of Cronobacter found in the facility. 

Abbott announced last week that he plant was resuming production of baby formula, saying certain formula would be back on shelves later this month. 

Nathaniel Weixel contributed to this report