HHS-OIG is putting FDA’s actions under review leading up to Abbott’s recall, to determine whether they acted properly, amid loud calls for accountability.
Highlights
- The Health and Human Services’ Office of Inspector General is launching an audit into how the Food and Drug Administration responded leading up to the massive recall of baby formula and closure of Abbott Nutrition’s Sturgis plant.
- Four infants were hospitalized with a rare but serious bacterial infection, two of whom ultimately died.
- The review of the FDA’s actions marks an extraordinary and uncommon move from the watchdog agency.
- The audit will determine if the FDA upheld its duty ’to safeguard the nation’s food supply, including infant formula and ensure all ingredients are safe’ Findings from OIG’s review are expected sometime in fiscal year 2023.
- Abbott maintains there is no conclusive evidence that its products contributed to the death of two infants.