The aforementioned inspection was conducted between August 25th to 29th, 2025.
The agency has issued an EIR (Establishment Inspection Report) on 18th Nov 2025 and determined that the inspection classification of the facility is ‘voluntary action indicated (VAI)’ and concluded this inspection as closed.
Sandeep Rao, MD & CEO said “We have successfully completed the FDA inspection at our Mangalore facility between 25th to 29th Aug 2025.
At the end of the inspection, two Form FDA 483 inspectional observations were issued by the investigator. The observations were procedural in nature.
We had submitted our formal response to FDA well within the timeline set by the agency and the agency has issued an EIR and concluded that the inspection is closed.”
Solara Active Pharma Sciences is a pure play global API manufacturer supported by R&D and manufacturing facilities.
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