Warning Letter to Zoll Medical for Major QMS Violations

by | Jun 19, 2026 | Device Warning Letters, Industry Information, Industry News, Med-Devices, Product Quality, Products_Devices, QMSR, Quality system, US-FDA

FDA Warning Letter ZOLL Medical Corporation QSR Violations Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts...

FDA Cites Data Integrity and OOS Failures at Intas Pharma

by | Apr 30, 2026 | Drug Warning Letters, Industry Information, Industry News, Inspections, Pharmaceuticals, Products_Drugs, Quality system, Reg_Products, US-FDA

FDA Warning Letter Intas Pharmaceuticals Limited Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts...

April 2026 Update for FDA QMSR Inspection Results

by | Apr 23, 2026 | Analytics, FDA Public Information, FOIA, Industry Information, Industry News, Inspections, Inspections, Med-Devices, Products_Devices, QMSR, Quality system, US-FDA

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact April 2026 Update for FDA QMSR...

Major Eye Drop Recall Shows Manufacturing and Inspection Issues

by | Apr 18, 2026 | Alerts-Pharma, Consumer Information, Consumer Safety, Industry Information, Industry News, MedWatch-System, Product Quality, Product Recalls, Products_Drugs, Quality system, Sterilization

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Massive eye drop recall reflects...

When a Small Process Failure Becomes a Patient Safety Event

by | Mar 23, 2026 | Analysis, Editorial, ISO 14971, Med-Devices, Product Design, Product Quality, Products_Devices, QMSR, Quality system, Reg_Information, Reg_Products, US-FDA

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the...