Tue Dec 03 22:07:12 UTC 2024: ## Granules India Faces US FDA Scrutiny After Gagillapur Facility Inspection
**Hyderabad, India – October 26, 2023** – Granules India, a leading pharmaceutical company, has announced that the US Food and Drug Administration (US FDA) has issued an “Official Action Indicated” (OAI) classification following an inspection of its Gagillapur facility in Hyderabad. The September inspection resulted in a Form 483 with six observations.
In response, Granules India has submitted detailed responses to the FDA’s observations and initiated a comprehensive facility evaluation with the assistance of external experts. The company is committed to working closely with the US FDA to address the concerns and bring the facility into full compliance. Granules India expressed confidence in resolving the issues promptly. This announcement was made as part of the company’s regulatory disclosure obligations.
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