FDA 483 - Marksans Pharma Limited - August 04, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 7e072b93-a247-49bb-a6f3-6a6e0f4a83e5