Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistNatco Pharma Limited, an Indian pharmaceutical manufacturer, was cited for significant violations of Current Good Manufacturing Practice (CGMP) regulations during an October 2023 FDA inspection of its drug manufacturing facility. The company failed to adequately clean and maintain non-dedicated equipment, with inspectors discovering residues of multiple active pharmaceutical ingredients exceeding allowable limits on equipment labeled as "cleaned," including equipment units VS/034 and T/020. These deficiencies rendered the firm's drug products adulterated under federal law, as the cleaning procedures were insufficient to prevent contamination that could alter the safety, identity, strength, quality, or purity of finished pharmaceuticals. The FDA's findings indicated systemic gaps in equipment maintenance and sanitation protocols across multiple pieces of non-dedicated manufacturing equipment.