FDA 483 - GRANULES LIFE SCIENCES PRIVATE LIMITED - December 19, 2025

Granules Life Sciences Pvt Ltd, a drug product manufacturer in Medchal-Malkajgiri, India, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate cleaning validation and equipment maintenance, poor environmental control with widespread powder contamination, and a systemic failure to properly investigate and handle out-of-specification results, often invalidating initial failures based on retesting without proper root cause. Additionally, the firm lacked adequate written procedures for process controls and failed to ensure quality unit approval for site layout designs.