FDA 483 - Granules India Limited - June 20, 2025

Granules India Limited, an API manufacturer in Sangareddy District, Telangana, India, was cited for significant failures in documenting and investigating deviations from established procedures. Observations included the approval of a Quality Comparison Report with an incorrect drug name that went uninvestigated for an extended period, and uninvestigated out-of-specification differential pressure readings in a cleanroom corridor. These issues highlight deficiencies in the firm's quality system and deviation management.