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Granules India Limited, a drug manufacturer in India, violated Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in August-September 2024. The company failed to establish and follow adequate written procedures for cleaning and maintenance of equipment, resulting in significant contamination detected in non-dedicated ducts used in drug product preparation, including residues from multiple previously manufactured drugs and excessive microbial contamination (TNTC levels). These manufacturing deficiencies rendered the company's drug products adulterated, as their methods, facilities, and controls did not conform to federal CGMP requirements under 21 CFR parts 210 and 211.