FDA 483 - Sun Pharmaceutical Industries Limited- Madhuranthagam - February 17, 2023

An FDA inspection of Sun Pharmaceutical Industries Limited- Madhuranthagam, an API manufacturer, revealed that laboratory testing was not performed under controlled conditions. Specifically, the firm failed to maintain required humidity control during the handling and testing of a highly hygroscopic API and lacked adequate procedures to minimize environmental exposure during multiple tests. This indicates a significant lapse in quality control for critical product testing.