USFDA23 May 2025, 05:51 pm
Hikal Ltd Receives US FDA Inspection Classification of 'Official Action Indicated' for Jigani Facility
AI Summary
Hikal Ltd has received communication from the US FDA that the inspection outcome of their manufacturing facility at Jigani, Bengaluru, Karnataka from February 3rd to February 7th, 2025, has been classified as 'Official Action Indicated' (OAI). The company believes this classification will not affect business continuity or existing product supplies from this facility. Hikal Ltd is committed to working closely with the US FDA and maintaining high quality and compliant manufacturing standards.
Key Highlights
- Hikal Ltd's Jigani facility received an 'Official Action Indicated' (OAI) classification from the US FDA.
- The company believes this classification will not impact business continuity or existing product supplies.
- Hikal Ltd is committed to working closely with the US FDA and maintaining high quality and compliant manufacturing standards.