FDA 483 - HP Halden Pharma AS - September 03, 2019

Fresenius Kabi Norge As, a sterile drug manufacturer in Halden, Norway, was cited for three observations related to quality system deficiencies. The firm failed to submit a Field Alert Report for a distributed drug product that failed stability specifications and did not thoroughly review batch failures. Additionally, the quality control unit's procedures for characterizing particles found during AQL testing were not adequately documented or followed.