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AmerisourceBergen settles dispute over multiple facilities with US FDA, DOJ

AmerisourceBergen Corp. agreed to settle its dispute with the U.S. Food and Drug Administration and the consumer protection branch of the civil division of the Department of Justice regarding its commercial and administrative facilities.

Under the settlement, AmerisourceBergen's unit PharMEDium can continue commercial operations at its facilities in Dayton, N.J., and Sugar Land, Texas, along with administrative operations at PharMEDium's Lake Forest, Ill., headquarters after complying with certain requirements.

Additionally, the company has agreed to arrange for an audit inspection of its commercial facilities by an independent current good manufacturing practices expert within 60 days and will also conduct annual inspections for four years.

The company must get a notice of compliance from the FDA before resuming commercial operations at its Memphis, Tenn., facility.

The FDA has asked the company to implement an approved work plan and conduct an audit inspection to certify that facilities, methods and controls at the Memphis facility and PharMEDium's headquarters meet the regulator's requirements. AmerisourceBergen will have to conduct annual inspections of the Memphis facility for an additional five years.

PharMedium has the option to ask the U.S. District Court for the Northern District of Illinois for relief if it remains in continuous compliance with the terms of the agreement for at least five years.

AmerisourceBergen's unit stopped production at its Cleveland, Miss., facility in April and has agreed that it will not hold and distribute drugs from that location after May 24.

The settlement is subject to the approval of the U.S. District Court for the Northern District of Illinois.