FDA 483 - Granules India Limited - January 13, 2023

Granules India Limited, a drug product manufacturer in Telangana, India, was cited for significant deficiencies in quality control and manufacturing processes. Observations included failures to thoroughly investigate out-of-specification results, unrecorded deviations from procedures, and a lack of adequate written procedures and process understanding for drug product manufacturing and validation. These issues indicate a systemic weakness in ensuring drug product identity, strength, quality, and purity.