USFDA5 Mar 2026, 11:45 am
Granules India’s US Packaging Facility Gets FDA EIR with No Action Indicated Status
AI Summary
Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC, has received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) Status from the US Food and Drug Administration (FDA). The FDA inspection was conducted at the company’s packaging facility in Manassas, Virginia, from December 1 to 3, 2025. This marks the facility’s second FDA inspection, following the March 2023 audit, which also concluded with zero observations.
Key Highlights
- Granules Consumer Health received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) Status from the US FDA.
- The inspection was conducted at the company’s packaging facility in Manassas, Virginia, from December 1 to 3, 2025.
- This is the facility’s second FDA inspection, following the March 2023 audit, which also concluded with zero observations.
- Granules Consumer Health serves as Granules’ front-end division for OTC products in the U.S.
- The facility is responsible for packaging both OTC and prescription (Rx) products and serving as a distribution hub for OTC products across the US.