SLOW(ER) RESPONSE

Abbott Alerted to Product-Safety Concerns Months Earlier Than Previously Known

The company became aware of concerns in February 2021, but the FDA only acknowledged a complaint that came eight months later.

According to sources for and documents reviewed by the Wall Street Journal, Abbott was alerted to product-safety issues at its Michigan infant-formula plant in February, 2021, shifting the publicly-acknowledged timeline of public-safety concerns up by months. A complaint filed under the U.S. Labor Department in February, 2021 by a former employee alleged a range of problems at the facility, including failing equipment and inadequately tested formula, a person familiar with the incident told the Journal. A government official told the newspaper that the Labor Department gave the complaint to Abbott and the FDA that same month, and that Abbott submitted a formal response two months later, saying that they could not confirm the allegations. Yet in the timeline presented at congressional hearings last month, the FDA only acknowledged a complaint about product-safety concerns that was filed by the same employee in October, 2021—eight months after the initial filing.