Solara’s Mangalore Site Clears US FDA Inspection with VAI Status

20 Nov 2025 CW Team

Solara Active Pharma Sciences has announced the successful completion of the US Food and Drug Administration (US FDA) inspection at its multi-product Active Pharmaceutical Ingredient manufacturing facility in Mangalore, Karnataka. The inspection, conducted from 25 to 29 August 2025, concluded with the issuance of an Establishment Inspection Report (EIR) on 18 November 2025. The Agency classified the facility as “Voluntary Action Indicated” (VAI), confirming continued compliance with current Good Manufacturing Practices (cGMP) and formally closing the inspection.

According to the company, the US FDA issued two procedural Form 483 observations at the end of the inspection. Solara submitted a comprehensive response within the stipulated timeframe, following which the Agency acknowledged the adequacy of the corrective actions and closed the inspection. The company noted that the outcome reflects its commitment to regulatory excellence, robust quality systems and adherence to global compliance standards across all manufacturing sites.

The Mangalore facility is equipped with multiple independent production blocks and packaging units, enabling supply of a wide portfolio of APIs. It is also regularly inspected by leading global regulatory bodies, including EDQM, HPRA, TGA, WHO, PMDA and MFDS Korea. Solara stated that maintaining world-class quality and compliance remains central to its long-term growth strategy.

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