FDA Concludes Oversight Shortcomings After Infant Formula Internal Review

FDA Concludes Oversight Shortcomings After Infant Formula Internal Review
  • The FDA concluded an internal review of agency actions related to the U.S. infant formula supply.
  • The agency released a 10-page report, which is the result of information collected from more than 40 interviews with more than 60 FDA staff and leadership directly involved with the events that transpired. 
  • The review found that numerous shortcomings hampered the agency’s response to the U.S. infant formula supply problems this year.
  • The FDA said a “confluence of systemic vulnerabilities” helped explain the events surrounding a product recall by Abbott Laboratories ABT, which worsened an existing supply shortage.
  • Related: Baby Formula Startup Seeks To Compete Abbott With 15% Market Share.
  • The report said that problems ranged from outdated technology to limited staff. 
  • Abbott shut down its largest formula factory in Sturgis, Mich., in February because of safety concerns related to some of its Similac products. 
  • The FDA’s report said the infant-formula industry uses “dated technology and record-keeping practices” that can delay gathering essential information for product recalls.
  • The FDA found that some samples taken from the Abbott Nutrition facility in Sturgis were delayed in transit. The evaluation also highlighted that the FDA’s regulatory laboratories face challenges in rapidly expanding testing capacity for Cronobacter.
  • The agency also highlighted that conditions observed at the Abbott Nutrition facility were inconsistent with a strong food safety culture.
  • Price Action: ABT shares closed at $102.31 on Tuesday.
Posted In: BriefsNewsHealth CareFDAGeneral