Abbott Laboratories Ltd
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Latest From Abbott Laboratories Ltd
Commissioner Robert Califf wants Janet Woodcock to improve food operations and processes, but lawmakers question whether she is the best overseer for the area.
Decree imposes steps Abbott must complete before it can begin preparing to restart production, including hiring independent consultant to determine whether facility is compliant with FDA manufacturing and labeling regulations.
FDA report on inspection states Abbott and agency “found evidence" of Cronobacter species bacteria in powdered infant formula production environment and firm also identified bacteria in finished powdered formula products. Once Abbott gets FDA clearance to restart production at facility, it will need as much as two months before formula made there reaches stores.
FDA launches temporary enforcement discretion on infant formula product to help increase supply in US on same day consent decree announced to allow Abbott to restart production at facility closed since February, prompting ongoing formula shortage.