Granules India Limited announced on June 3, 2026, 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). The classification for the facility is Voluntary Action Indicated (VAI). The USFDA inspection for the Chantilly facility was conducted from March 30 to April 3, 2026. During this inspection, four Form 483 observations were issued. This facility is noted as playing an important role in Granules' global manufacturing and supply network. The company emphasizes its continued focus on quality systems, regulatory compliance, and patient safety at this site. Granules reiterates its commitment to maintaining the highest standards of quality, safety, and regulatory compliance across all its manufacturing facilities in India and the US.
