FDA 483 - Granules India Limited - September 06, 2024

An FDA inspection of Granules India Limited, a drug product manufacturer in Medchal-Malkhajgiri District, Telangana, revealed significant GMP deficiencies. Observations included inadequate cleaning of equipment leading to potential cross-contamination and microbial growth, failures in thoroughly investigating out-of-specification and out-of-trend results, and deficiencies in quality control unit procedures and facility maintenance. These issues indicate a lack of control over manufacturing processes and product quality.