Medical Device and Pharmaceutical News
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FDA Early Alert for GE HealthCare Infant Resuscitation Systems
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Due to Oxygen Blender Issue Early Alert for GE HealthCare Infant Resuscitation Systems The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
Warning Letter Cites Serious Deficiencies at Pharma Facility
Serious Sterility and CGMP Deficiencies at ProRx Outsourcing Facility The FDA has issued a significant Warning Letter to ProRx LLC, an FDA-registered outsourcing facility located in Exton, Pennsylvania, citing major violations involving sterile drug compounding...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New Pathway in Stroke Recovery A company behind one of the world’s most closely watched neurorehabilitation technologies is preparing for a major new...
FDA Cites Data Integrity and OOS Failures at Intas Pharma
FDA Warning Letter: Data Integrity and OOS Failures at Intas Pharmaceuticals Limited The U.S. Food and Drug Administration issued a Warning Letter to Intas Pharmaceuticals Limited citing significant violations of Current Good Manufacturing Practice (CGMP) at its...
FDA Warning Letter Cites Systemic Aseptic Manufacturing Failures
Medline Warning Letter Signals Systemic Quality Failures in Cardiovascular Device Manufacturing The FDA has issued a Warning Letter to Medline Industries (NAMIC Division) following a December 2025 inspection, identifying significant Quality System Regulation (QSR)...
FDA Approves First Gene Therapy for Genetic Hearing Loss
FDA Approves First Gene Therapy for Genetic Hearing LossRapid Review and Breakthrough Science Converge in Landmark OTOF Therapy The FDA has approved Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss caused by mutations in...
April 2026 Update for FDA QMSR Inspection Results
April 2026 Update for FDA QMSR Inspection ResultsConfirming the Shift to System-Level, Risk-Based Inspection When FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026, the regulatory framework became formally aligned with ISO 13485. What...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...