Abbott Diabetes Care Gets 483 for Complaint Procedures
An FDA investigator cited Abbott Diabetes Care for complaint handling and employee training in a Form 483 that included three observations.
The company received the Form 483 in March after an inspection of its facility in Alameda, Calif., for operations related to the FreeStyle Navigator continuous glucose monitoring system.
Staff did not complete training for complaint procedures or device failure investigations, and the company did not appropriately evaluate a complaint to determine if a medical device report was needed. The complaint came from a customer “who was using the Navigator and was in pain and wanted to return the system,” the form says.