USFDA1 Oct 2026, 02:35 pm
Jeevan Scientific Technology: US FDA Inspection Closed with No Observations
AI Summary
Jeevan Scientific Technology Ltd announced the successful closure of its United States Food and Drug Administration (US FDA) inspection for its Bioanalytical Facility in Manikonda, Hyderabad. The inspection, conducted from July 20-24, 2026, concluded with zero observations (no 483s). The company received the Establishment Inspection Report (EIR) on September 30, 2026, confirming the successful conclusion of the inspection under 21 CFR 20.64(d)(3). This positive outcome is a significant regulatory milestone for the company.
Key Highlights
- US FDA inspection of Bioanalytical Facility successfully closed.
- Zero observations (no 483s) issued by the US FDA.
- Establishment Inspection Report (EIR) received on September 30, 2026.
- Inspection conducted from July 20-24, 2026.
- Positive regulatory outcome for Jeevan Scientific Technology.
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