by Bruce Waldon | Dec 13, 2025 | Dietary Supplements, DSHEA, Editorial, FDA Enforcement, Industry Information, Industry News, Legislation, MedWatch-System, Product Quality
Do Not Blame FDA for Lax Oversight of Dietary Supplements MDP Policy Commentary Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers A Regulatory System Designed to Fail The recent...
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 Devices and Pharma | Apr 18, 2024 | FDA Enforcement, US-FDA
FDA Enforcement Maintaining the safety, efficacy, and quality of regulated products Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The Food and Drug Administration...
by Devices and Pharma | Mar 19, 2023 | FDA Enforcement, FDA Warning letters, Med-Devices, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA)...