USFDA4 Dec 2025, 12:12 pm
Granules India’s US Packaging Facility Achieves Zero Observations in FDA Inspection
AI Summary
Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC, successfully completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations. This was the facility's second FDA inspection, following the March 2023 audit that resulted in a No Action Indicated (NAI) classification. The facility plays a critical role in the company's global operations as a packaging and distribution site, processing controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Achieving zero observations in this inspection reflects the company's unwavering focus on quality, safety, and regulatory excellence.
Key Highlights
- Granules India’s US packaging facility completes FDA inspection with zero observations
- This is the facility's second FDA inspection, following the March 2023 audit that resulted in a No Action Indicated (NAI) classification
- The facility plays a critical role in the company's global operations as a packaging and distribution site
- The facility processes controlled substances and over-the-counter (OTC) products across three advanced packaging lines
- Achieving zero observations reflects the company's unwavering focus on quality, safety, and regulatory excellence