FDA 483 - Solara Active Pharma Sciences Limited - August 29, 2025

Solara Active Pharma Sciences Limited, an API manufacturer in New Mangalore, India, was cited for significant quality system deficiencies during an FDA inspection. The firm's Quality Unit failed to adequately investigate product complaints involving foreign particle contamination and neglected to review multiple pest alerts. Additionally, the facility lacked proper handwashing facilities with hot water and soap in manufacturing areas.