Inspections and Audits

EpiPen Manufacturer Bungled Response to Complaints of Failures, FDA Says

A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter. Read More