EU Issues Track-and-Trace Drug Packaging Rules
The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Source: Drug GMP Report
FDA Issues 483 to Novo Nordisk for Inadequate Sterility Controls
The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Source: Drug GMP Report
Form 483 Hits the SweetSpot for Alleged Follow-up Issues
The FDA cited a diabetes device data firm for alleged procedural failings in a recent FDA Form 483. Source: The GMP Letter
Cook Medical Recalls Beacon Tip Catheters
Cook Medical is recalling 408,011 of its Beacon Tip Catheter in U.S. markets, due to complaints that the catheter tip may split or separate and could potentially enter the patient’s…
Senate HELP Committee Advances Scope Safety Bill as Part of Biomedical Innovation Agenda
The Senate HELP Committee unanimously advanced to the full Senate a bill that would give the FDA additional tools to review and ensure the safety of medical devices, such as…
Firm Cited for Neglecting MDR Reporting Patient Death
Device manufacturer Moss Tubes has been cited for multiple alleged reporting violations tied to product failures, one of which apparently resulted in a patient death. Source: The GMP Letter
Arkray Recalls Test Strips Due To Inaccurate Readings
Arkray is recalling certain test strips due to inaccurate blood sugar readings. Source: The GMP Letter
Sientra Returning All Products to U.S. Market Following Removal
Sientra is planning to return all of its medical devices — including breast implant products — to the U.S. market starting March 1. Source: The GMP Letter
Dräger Recalls Emergency Transport Ventilators
Dräger is recalling 117 emergency transport ventilators due to a system error that may lead to a halt in ventilation therapy. Source: The GMP Letter
Expert: ISO 13485 Could Cause Confusion With FDA’s Quality System Regulation
Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Source: The GMP Letter