Granules India's Hyderabad Facility Receives 11 US FDA Observations

Photo: Hindu Business

Granules India's finished dosage facility in Gagillapur, Hyderabad, received 11 observations from the US FDA after an inspection from October 19-30, 2026. The observations, detailed in Form FDA 483, focus on improvements in investigations, change control, process and equipment qualification, visual inspection, and documentation. None relate to data integrity or cross-contamination. Manufacturing and distribution remain unaffected. A comprehensive response will be submitted to the FDA.

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