USFDA8 Sept 2024, 06:16 pm
Suven Pharmaceuticals' Subsidiary Receives US FDA Inspection Report with 'Voluntary Action Indicated' Status
AI Summary
Suven Pharmaceuticals Ltd. provides an update on the US FDA inspection at the formulation manufacturing facility of its wholly owned subsidiary, Casper Pharma Private Limited, located in Hyderabad. The company received the Establishment Inspection Report (EIR) with the US FDA categorizing the inspection as 'Voluntary Action Indicated' (VAI) and closing it under 21 CFR 20.64(d)(3).
Key Highlights
- Suven Pharmaceuticals' subsidiary, Casper Pharma Private Limited, underwent a US FDA inspection at its formulation manufacturing facility in Hyderabad.
- The company received the Establishment Inspection Report (EIR) from the US FDA.
- The US FDA has classified the inspection as 'Voluntary Action Indicated' (VAI).
- The inspection has been officially closed under 21 CFR 20.64(d)(3).
- This update follows the company's previous intimation dated July 13, 2024.