Federal investigators to review FDA response to baby formula recall
June 2 (Reuters) - Federal investigators have launched a review into whether the U.S. Food and Drug Administration properly inspected Abbott Laboratories' (ABT.N) Michigan plant and how the agency oversaw the baby formula recall that led to severe U.S. shortages.
The review, which is expected to be completed in 2023, will be conducted by the U.S. Department of Health and Human Services' Office of Inspector General (OIG), according to a notice posted on its website on Thursday.
OIG will investigate the FDA's actions leading up to the recall in February.
"We will determine whether FDA followed the inspections and recall process for infant formula in accordance with federal requirements," OIG said.
Lawmakers grilled FDA officials last week over what they saw as a lack of urgency in the agency's response to complaints about possible baby formula contamination at the Michigan plant. read more
The FDA started its inspection of the plant in late January following reports of bacterial infections in babies potentially linked to Abbott's formula.
Abbott subsequently closed the plant and recalled baby formula made there, deepening a nationwide shortage that has left parents scrambling to feed their babies.
U.S President Joe Biden has since invoked the Cold War-era Defense Production Act to shore up supplies, and manufacturers have been importing baby formula.
Roughly 73% of baby products are out of stock nationwide as of May 22, according to data firm Datasembly.
The FDA said on May 19 it expects the plant to reopen within one or two weeks. read more
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