The federal complaint, which was filed May 20, alleged the company made the following FDA violations between 2014 and 2021: failure to meet sterility minimums, labeling inadequacies, improper airflow, structural disrepair, record-keeping disparities and mold in cleanroom suites, according to the Justice Department.
Edge Pharma did not deny or confirm the allegations of supplying adulterated and misbranded prescriptions, but said it planned to settle the suit.
