The FDA has released an internal review that examines how the agency handled the months-long infant formula crisis
A perfect storm of"systemic vulnerabilities" at the US Food and Drug Administration unfolded as the agency investigated contaminated baby formula, hampering its response to a worsening baby formula shortage, a new internal review shows.
The FDA's investigation of bacterial contamination in baby formula in January ultimately resulted in a recall of many popular formula brands and forced the shutdown of a major manufacturing plant. The moves exacerbated shortages caused by supply chain disruptions, which still have not been fully remedied. FDA Commissioner Dr. Robert Califf announced earlier this year that he had appointed an agency veteran to lead its internal review, which was released on Tuesday.
"The situation at the Abbott Sturgis facility has highlighted just how little authority the FDA has to compel many companies to 'do the right thing' without intervention," Califf said in a statement. "Rest assured that we are committed to implementing the necessary changes to help us avoid future supply shortages and ensure parents and caregivers have access to safe and nutritious infant formula whenever and wherever they need it.
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