For instance, the agency took more than 15 months to act on a whistleblower complaint about dangerous conditions at the Abbott plant that was first filed in February 2021. 

The Department of Labor received the complaint and forwarded it to FDA three days later, but FDA did not identify the complaint until June 7, 2022. 

“The complaint alleged that the Abbott facility engaged in practices that violated laws, regulations, and other guidance that FDA administered and enforced,” the report said. 

“At the time of the initial submission of the February 2021 whistleblower complaint, FDA did not have adequate policies and procedures for identifying and investigating whistleblower complaints received in the dedicated FDA email inbox.” 

The agency received a second warning from the same whistleblower several months later, in October 2021.  

But according to the report, FDA “did not escalate [the October 2021] whistleblower complaint to senior leadership, resulting in a nearly 4-month delay before senior leadership was aware of the complaint.”