FDA 483 - Sciegen Pharmaceuticals Inc - January 09, 2015

An FDA inspection of Sciegen Pharmaceuticals Inc. in Hauppauge, NY, revealed that the firm's quality control unit procedures were not fully followed. Specifically, a laboratory investigation into duplicate sample sets for Metformin Hydrochloride Tablets was deemed inadequate. The firm failed to determine the root cause of the event and did not conduct a comprehensive review of electronic files and associated audit trails.