Syngene Gets FDA Nod on Biocon Park Inspection With VAI Status

15 Jun 2025 , 09:00 PM

Syngene International has received a follow-up from the U.S. FDA related to an inspection earlier this year at one of its manufacturing sites near Bengaluru. The company shared the update in a stock exchange filing on Friday.

The company said the FDA has issued an Establishment Inspection Report (EIR) dated June 11, following a routine audit carried out between February 10 and 20 this year. The outcome of the inspection has been classified as “Voluntary Action Indicated” or VAI.

That term might sound serious, but in FDA language, it means the agency found a few things that needed fixing but didn’t see enough cause to push for formal penalties or further oversight.

Syngene said that the FDA had reviewed its response and was satisfied with the company’s explanation and its plans for correcting the issues. The company also committed to sharing regular updates with the agency as it moves through those changes.

They were clear about one thing: this won’t affect business. There’s no expected hit to revenue, operations, or ongoing work with clients. In fact, they described it as part of a healthy regulatory cycle. The inspection took place from February 10 to 20, and the FDA’s final response was dated June 11.

The company’s facilities at Biocon Park are core to its operations. They handle everything from early-stage R&D to commercial manufacturing. With global clients on the books and regulatory scrutiny always in play, keeping facilities compliant is part of the day-to-day.

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