FDA 483 - Sciegen Pharmaceuticals Inc - September 16, 2011

Sciegen Pharmaceuticals Inc. in Hauppauge, NY, was cited with two observations during a pre-approval inspection. The firm lacked scientifically sound laboratory controls for assigning expiry periods to volumetric solutions without stability data. Additionally, procedures were not established to prevent objectionable microorganisms, specifically concerning the purified water system's delivery hose.