FDA inspectors found Abbott failed to determine if complaints involving problems with infant formula products were linked to manufacturing issues that posed a larger health threat.
FDA inspectors found Abbott knew about the problems with the recalled infant formula months in advance, but failed to conduct a proper investigation and quality control measures.
Poor quality control issues at a Michigan production plant may have contributed to Similac contamination which led to a massive baby formula recall last month.
The first case of Salmonella or Cronobacter infection from Similac was discovered in September 2021, but it was another four months before problems resulted in a recall or warnings for parents
Information indicates Abbott received complaints about the Similac, Alimentum and Elecare contamination as early as September of 2021.
Additional lots of Similac powdered formula have been recalled over possible contamination with Salmonella Newport, Cronobacter sakazaki and other bacteria that has caused children nationwide to experience severe illness
