Granules India Limited – FDA 483, Sep 6, 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.
ID · a1f3c886-70bc-49f9-8761-a7e47ae7aa46
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