Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistBaxter Healthcare Corporation's India-based pharmaceutical manufacturing facility failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished drug products, rendering them adulterated. Investigators found that the firm did not conduct thorough investigations into specification failures, particularly regarding unexplained discrepancies in endotoxin testing and automated visual inspection systems, and failed to implement scientifically-supported root cause analyses or appropriate corrective and preventive actions (CAPA). Specifically, the company invalidated multiple endotoxin tests for finished products when particulate matter was discovered in assay wells but did not adequately characterize the contamination or establish proper investigative scope.