FDA 483 - Solara Active Pharma Sciences Limited - July 27, 2018

An FDA inspection of Solara Active Pharma Sciences Limited in New Mangalore, Karnataka, India, revealed significant deficiencies in their manufacturing and laboratory controls. Observations included inadequate written procedures for equipment cleaning and a lack of validation for cleaning processes. Additionally, the firm's method validation for forced degradation studies of active pharmaceutical ingredients was found to be insufficient.