FDA Took Over a Year to Act on Whistleblower Tip About Abbott Nutrition, New Audit Finds

By Madz Dizon

Jun 14 2024, 03:17 AM EDT

FDA Took Over a Year to Act on Whistleblower Tip About Abbott Nutrition, New Audit Finds — An Abbott Laboratories logo is visible on a security gate near its headquarters February 10, 2004 in Abbott Park, Illinois. Tim Boyle/Getty Images

A recent audit reveals that it took the US Food and Drug Administration over 15 months to respond to a whistleblower complaint regarding the conditions at an Abbott Nutrition factory.

This factory was responsible for a nationwide shortage of infant formula.

FDA Slow to React to Abbott Formula Milk Complaint

According to AP News, the Department of Labor promptly received the email and subsequently forwarded it to an FDA address designated for handling such complaints.

However, one of the staff members responsible for managing the FDA inbox at the time accidentally archived the email in February 2021. It remained undiscovered until a reporter specifically requested it in June 2022.

The auditors criticized the FDA for not taking sufficient actions and conducting thorough follow-up inspections prior to the recall of Abbott powdered infant formula.

The report concluded that there is a need for improved policies regarding the reporting of complaint statuses to senior leaders and for expediting inspections.

Multiple infants were admitted to the hospital, and tragically, two lost their lives, due to a rare bacterial infection. The infection was linked to the powdered formula produced at Abbott's Michigan plant, which happens to be the largest in the country.

In February 2022, the FDA temporarily closed down the site and the company had to recall various batches of well-known formulas such as Similac, Alimentum, and EleCare.

After a thorough investigation, FDA inspectors discovered numerous violations at the plant. These included bacterial contamination, a leaky roof, and lax safety protocols. However, despite their findings, the agency was unable to establish a direct connection between the infections and the formula.

FDA's Probe

A dedicated team of investigators has been formed by the FDA to exclusively handle inspections and oversight of the infant formula industry, along with other critical foods. This move aims to ensure the safety and quality of these products, according to a spokesperson.

The FDA mentioned that it has also made improvements in tracking hard-copy mail items, which may include complaints.

Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, expressed his agreement with the recommendations put forth in the report.

He emphasized the importance of Congress granting the FDA the authority to mandate manufacturers to report any instances of infant formula contamination, regardless of whether the product has already left the factory, Click on Detroit reported.