Granules India Limited today announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, US, has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), with a Voluntary Action Indicated (VAI) classification.

The inspection was conducted from March 30 to April 3, 2026, during which four Form 483 observations were issued.

This facility plays an important role in Granules’ global manufacturing and supply network, with a continued focus on quality systems, regulatory compliance, and patient safety.

Granules remains committed to maintaining the highest standards of quality, safety, and regulatory compliance across its facilities in India and the US.