FDA Scrutiny of GLP-1 Manufacturers Signals Expanding Inspection Focus Beyond Traditional GMP Operations
Key Takeaways The FDA’s recent Warning Letter activity involving Novo Nordisk and semaglutide-related pharmacovigilance processes may represent another major signal that FDA inspections are evolving beyond traditional manufacturing floor oversight and into enterprise-wide quality systems evaluation. As demand for GLP-1 therapies such as Ozempic and Wegovy continues to surge globally, FDA investigators appear to be…