Medtronic was slapped with a 15-citation warning letter following a preapproval inspection for its MiniMed 530G continuous glucose monitoring system. Read More

FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More

King Systems has received an FDA warning letter over process validation, in-process testing, complaint handling and storage procedures. Read More