Abbott Laboratories, the company that makes up to one-fifth of the nation’s baby formula, knew about allegations of serious safety issues at a key manufacturing plant months earlier than was previously known, according to a report by The Wall Street Journal.
The newspaper reported Wednesday that Abbott was told in February 2021 that a whistleblower had filed an Occupational Safety and Health Administration (OSHA) complaint about problems at its Sturgis, Michigan plant. The issues included reports of failing equipment that may have allowed bacteria into the formula production process, the Journal reported.
The report adds new details to the timeline before Abbott shut down its formula plant in Sturgis in February of this year. The site is at the center of the nation’s ongoing formula shortage, which has been exacerbated by pandemic supply chain issues. The report also suggests officials at Abbott knew there were potential issues at the plant long before it shuttered the facility and recalled types of its formula nationwide, the Journal added.
A spokesman for Abbott told ABC News it investigated issues linked to the February complaint and had “not been able to confirm the allegations.” The company went on to say the former employee was fired due to “serious violations of Abbott’s food safety policies” and that the individual didn’t raise any safety concerns while working there.
Abbott did not mention the February OSHA complaint when it testified about the formula shortage in May.
Abbott closed the Sturgis plant and issued a nationwide recall after the FDA found traces at the facility of a potentially lethal bacteria, called cronobacter, that can cause serious illness in infants. The disclosure came the same time authorities were investigating the case of four infants who consumed Abbott formula and also contracted infections from the bacteria, which can live in dry, powdered foods.
Two of the babies died from their illnesses. The FDA said it can’t definitively link the presence of bacteria at Abbott’s Sturgis plant to the infants’ infections.
The Journal reported the OSHA discrimination complaint was filed in Michigan by a former Abbott employee who was fired in August 2020. A second complaint was filed with the federal OSHA in February 2021 and a third to the FDA in October 2021, all by the same individual.
The plant resumed operations last month, but the baby formula shortage is expected to remain until at least next month as the supply chain issues ease.
The FDA acknowledged ongoing concerns with the timeline before the Abbott plant was closed, but said it was focused on addressing the ongoing formula shortage as the Abbott facility comes back online.
“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 agency 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.”