Report: FDA warned about factory a year before formula recall
Testing widget old system
(NewsNation) — Abbott Laboratories learned of concerning issues at its Sturgis, Michigan, infant-formula plant months earlier than previously publicly known, according to the Wall Street Journal.
According to the report, a complaint was filed with the U.S. Labor Department’s Occupational Safety and Health Administration’s whistleblower protection program by a former Abbott employee in February 2021. Allegations included equipment in disrepair and formula being released for consumption without proper safety testing.
Later in October 2021, the same whistleblower expanded on the concerns in a complaint sent to the Food and Drug Administration. The agency, however, didn’t inspect the plant until the end of January 2022.
These complaint details offer a more complete picture of the timeline leading up to the February 2022 Sturgis plant shutdown — a full year after the initial claim was reportedly filed with OSHA. This has been a major contributor to the severe U.S. baby-formula shortage, as the factory produced about one-fifth of the infant formula in the U.S.
“Over 70% of our nation’s baby formula is out of stock . In my home district, I have a nine-month-old. They are rationing baby formula. This is the United States of America, folks. This is unacceptable,” said Rep. Elise Stefanik, R-N.Y.
In a statement sent to NewsNation, Abbott said it did not become aware of the complaint until it became public this past April.
“We believe this to be a former employee who was dismissed due to serious violations of Abbott’s food safety policies. While at the company, the former employee did not bring forward product safety complaints,” the company alleges.
Abbott restarted production in Sturgis last weekend under tight regulatory oversight.
The Wall Street Journal’s report led to scathing criticism against the Biden administration by Republicans on Thursday.
The baby formula shortage is expected to continue through July. To combat this, President Joe Biden launched Operation Fly Formula to bring close to 50 million bottles of formula to the U.S. from overseas.
“I’m thankful that Biden continues to do everything possible to deal with the shortage,” Rep. Hakeem Jeffries, D-N.Y., said.
