by MDP Staff | Jul 16, 2025 | Alerts, Cardiovascular, Device Warning Letters, FDA Enforcement, FDA Public Information, FDA Warning letters, Industry News, Med-Devices, QSR, Safety
FDA Cracks Down on Insightra Medical Unapproved use and serious quality violations found Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Cites a Number of Serious Violations In a...
by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Pharma, Consumer Safety, FDA Warning letters, Industry News, Unapproved Drugs
FDA Cracks Down on Companies Illegally Marketing 7-OH Products Products that contain 7-hydroxymitragynine (7-OH) Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Unapproved drugs sold online and...
by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Pharma, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, Product Safety
FDA Warning Letter to Daewoo Pharmaceuticals Co., Ltd. Multiple cGMP violations cited Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Cracks Down on Sterile Drug Manufacturing Violations The...
by MDP Staff | Jul 15, 2025 | Alerts, Alerts-Device, FDA_Innovation, Product Recalls, US-FDA
FDA Pilot Program Updates Recall Reporting The goal is to improve early communication Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Recall Communication “Early Alerts” Note: This summary is...
by MDP Staff | Jul 15, 2025 | Alerts, Alerts-Device, Class I Recalls, FDA Reports
BD Alaris Pump Module model 8100 Performance can worsen when connected to other perfusion sets Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall (Correction) The FDA has issued an...
by Devices and Pharma | Jul 10, 2025 | Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Products_Devices, Safety, US-FDA
AirLife/Vyaire Infant Breathing Systems Recall Potential for risk of disconnection Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall AirLife and manufacturer Vyaire are recalling...
