Solara Mangalore facility clears US FDA inspection with VAI classification

Solara Active Pharma Sciences Limited's multi-product manufacturing facility in Mangalore, Karnataka, successfully completed a US FDA inspection conducted from August 25 to 29, 2025. The US FDA issued an Establishment Inspection Report (EIR) on November 18, 2025, classifying the inspection as "Voluntary Action Indicated (VAI)" and closing it.

According to Sandeep Rao, managing director and chief executive, two Form FDA 483 inspectional observations, procedural in nature, were issued and addressed with a formal response to the FDA. This positive outcome underscores Solara's commitment to regulatory excellence and quality across its global manufacturing sites.

The Mangalore facility, which is equipped with independent production blocks and packaging sections, is also inspected by various other regulatory authorities, including EDQM, HPRA, TGA, WHO, PMDA, and MFDS, Korea.