FDA 483 - Hetero Labs Limited (Unit III) - August 28, 2014

An FDA inspection of Hetero Labs Ltd. Unit III in Nallapally Mandal, India, an intermediate manufacturer, revealed two significant observations. The firm failed to establish appropriate controls on computerized systems in the Quality Control Laboratory, specifically lacking audit trails for analytical equipment. Additionally, the accuracy, sensitivity, specificity, and reproducibility of HPLC test methods for intermediates were not established, with method transfer not performed for several intermediates.