FDA 483 - Hetero Drugs Ltd. - Unit 1

An FDA inspection of Hetero Drugs Limited, an API drug manufacturer, revealed significant deficiencies in laboratory control testing for Active Pharmaceutical Ingredients. The firm was found to have inhibited integration of HPLC peaks during related substance testing, which could mask impurities, and lacked adequate Standard Operating Procedures for chromatographic practices. These issues indicate a failure to ensure accurate and reliable data for drug products marketed in the United States.