Abraxis cited for problems with labeling, aseptic conditions.(HUMAN DRUGS)

Inspection Monitor | October 1, 2008 | Copyright

Abraxis Pharmaceutical Products, Melrose Park, IL, Chicago District

Investigators Carrie Ann Plucinski and Russell Riley gave Abraxis a three-item 483 after an inspection of the drug manufacturer Aug. 23-Sept. 28, 2007.

The inspectors found that Abraxis approved and released for use labeling and packaging materials that did not meet written specifications. The firm labeled one lot of Octreotide Acetate Injection with vial labels that incorrectly stated the concentration of the drug as 0.05 mg/mL rather than 0.5 mg/mL. The company had recently changed its ...

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