Before Infant Formula Recall, Abbott ‘Closed-Done’ With Investigation Complaint Referencing Death
Agency Officials' Report Critical Of Abbott's Complaint Investigation Procedures
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.
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DeLauro Whistles For Investigation Of US FDA Response To Whistleblower Report On Abbott Formula Facility
Appropriations chairwoman Rosa DeLauro wants answers from HHS Office of Inspector General about FDA’s response to whistleblower report of contamination at Abbott Nutrition infant formula facility. Report described pattern of unsatisfactory quality control practices at the plant.
OTC drug development and marketing consultants spoke with HBW Insight about FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule. In first of two articles, they discuss proposed rule’s likely impacts on industry and remaining concerns around incorporating extra-label information in drug labeling.
The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.