Drug News
FDA Says 49.1% Of Pharma Companies Failed To Report Safety Issues
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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
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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.
