Fre­se­nius Kabi pays $50 mil­lion to set­tle crim­i­nal charges

An In­di­an drug man­u­fac­tur­er has agreed to pay $50 mil­lion in fines and for­fei­tures, the US De­part­ment of Jus­tice an­nounced Tues­day. Fre­se­nius Kabi On­col­o­gy Lim­it­ed (FKOL) plead guilty to con­ceal­ing and de­stroy­ing records; the charges came in the wake of a 2013 US FDA in­spec­tion of its plant in Kalyani, In­dia.

“By hid­ing and delet­ing man­u­fac­tur­ing records, FKOL sought to ob­struct the FDA’s reg­u­la­to­ry au­thor­i­ty and pre­vent the FDA from do­ing its job of en­sur­ing the pu­ri­ty and po­ten­cy of drugs in­tend­ed for U.S. con­sumers,” said Act­ing As­sis­tant At­tor­ney Gen­er­al Bri­an Boyn­ton of the Jus­tice De­part­ment’s Civ­il Di­vi­sion in a press re­lease an­nounc­ing FKOL’s guilty plea. “FKOL’s con­duct put vul­ner­a­ble pa­tients at risk. The De­part­ment of Jus­tice will con­tin­ue to work with the FDA to pros­e­cute drug man­u­fac­tur­ers who ob­struct these in­spec­tions.”

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