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Syngene International Ltd received a clean Establishment Inspection Report from the US FDA for its Semicon Park facility in Bengaluru. The inspection ended with zero observations and a VAI outcome. Syngene International Ltd share price closed at Rs.652.45 on Friday.
Syngene International Ltd has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Good Manufacturing Practices (GMP) facilities at Semicon Park, Bengaluru. The inspection, which took place from February 10 to 20, 2025, concluded with zero observations and a Voluntary Action Indicated (VAI) classification.
According to the company’s filing on June 13, the FDA has accepted Syngene’s post-inspection responses and corrective and preventive action (CAPA) plans. The company will continue to submit periodic updates to the regulatory agency, although the outcome does not trigger any further regulatory action.
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US FDA conducted routine inspection from February 10–20, 2025
Establishment Inspection Report (EIR) received with zero observations
Outcome classified as Voluntary Action Indicated (VAI)
FDA has accepted Syngene’s CAPA responses
Financials and daily operations remain unaffected
Syngene International Ltd share price closed at Rs.652.45 on BSE
Also read: US FDA flags 8 observations at Sun Pharma's Halol plant post audit
A VAI classification means that while some issues may have been identified, they were not serious enough to warrant additional regulatory enforcement. It also reflects the regulator’s confidence in Syngene’s quality controls and response process.
Detail | Status/Value |
Facility Location | Semicon Park, Bengaluru |
Inspection Period | February 10–20, 2025 |
Inspection Outcome | Voluntary Action Indicated (VAI) |
Number of Observations (Form 483) | Zero |
CAPA Plan Review Status | Accepted by US FDA |
Impact on Financials and Operations | No adverse impact |
Syngene International Ltd share price | Rs.652.45 (as of June 13, 2025) |
This successful audit outcome strengthens Syngene’s regulatory track record and reaffirms its commitment to maintaining high standards across its global supply chain. With zero critical findings and no regulatory penalties, the company can continue its manufacturing and research activities without interruption.
Syngene International Ltd share price may remain steady, supported by the absence of regulatory red flags and the company’s proactive compliance strategy.
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Source: CNBCTV18
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