Nearly half of drugmakers didn't report safety issues to FDA

 From 2018 to 2021, 49.1 percent of global pharmaceutical companies selling products in the U.S. did not submit field alert reports, which are required to be sent to the FDA within three days of a potential defect or safety issue, according to an agency report. 

Nearly two-thirds of foreign drug manufacturers and 38.9 percent of domestic facilities failed to submit FARs during the four-year period, the FDA's Office of Pharmaceutical Quality found.

Although most of the sites handled non-sterile products, the missing FAR reports can include anything from a mislabeled batch to bacterial contamination. 

The report did not specify which facilities failed to alert the FDA about potential safety problems.

https://www.beckershospitalreview.com/pharmacy/nearly-half-of-drugmakers-didn-t-report-safety-issues-to-fda-report-finds.html