FDA 483 - Marksans Pharma Limited - August 04, 2023

An FDA inspection of Marksans Pharma Limited in Vasco Da Gama, Goa, India, identified significant deficiencies in the firm's adverse drug experience (ADE) reporting and post-marketing surveillance systems. The company failed to submit required 15-day reports for serious and unexpected ADEs found through literature searches. Additionally, the firm lacked comprehensive written procedures for managing ADEs, including those from literature, contracted vendors, online sources, and for signal detection.