FDA 483 - Marksans Pharma Limited

Marksans Pharma Limited, a non-sterile drug manufacturer in Verna, Goa, was cited for eight observations during an FDA inspection. The findings primarily concern deficiencies in quality control unit responsibilities, stability programs, change control for packaging, complaint investigations, microbial testing procedures, laboratory controls, and cleaning procedures. These issues indicate a lack of robust quality systems to ensure product quality and compliance with cGMP regulations.