Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical

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...

FDA Enforcement

by Bruce Waldon | 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...

FDA Warning Letter to Olympus Medical Systems

by Bruce Waldon | 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)...

FDA Warning Letter to Jackson Clinic

by Bruce Waldon | Mar 12, 2023 | Consumer Information, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA)...

FDA Posts Warning Letter to MicroVention Costa Rica

by Bruce Waldon | Mar 1, 2023 | Alerts, FDA Enforcement, FDA Warning letters, Industry News, Med-Devices, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to...

FDA Information – Conveniently Organized and Accessible

by Bruce Waldon | Dec 31, 2022 | Consumer Information, FDA Enforcement, FDA Public Information, Industry News, Med-Devices, Pharmaceuticals, Product-Innovation, Reg_Information, US-FDA

FDA Information - Conveniently Organized and Accessible Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Quickly find the FDA information you need Conveniently...