Simplifying Global Compliance
View Archived Issues
June 2019
No. 473
Headlines
Full Issue of The GMP Letter in PDF Format
Download and view the full issue. Read More
Health Canada Issues Final Guidance on 3D-Printed Implantable Devices
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Read More
European Commission Clarifies What UDI Info Is Needed for Eudamed
The European Commission released new details on what datasets devicemakers should include in the Eudamed database for unique device identifiers under the new Medical Device Regulation and In Vitro Diagnostic Regulation. Read More
Warning Letter Roundup: FDA Flags Four Firms for Quality
The FDA issued warning letters to devicemakers in Michigan, Nevada, Idaho and Texas for numerous quality failures. Read More
Sloppy Validation, Complaint Handling Found at Duke Empirical
Process validation issues and failure to document complaints and corrective and preventive actions landed devicemaker Duke Empirical an FDA Form 483 following a Dec. 3-21, 2018, inspection of its Santa Cruz, California plant. Read More
Singapore Diagnostics Maker Fails to Establish SOPs for Investigations
Failure to establish standard operating procedures for investigations landed Singapore-based diagnostics maker MP Biomedicals Asia Pacific in hot water with the FDA following a Dec. 10-12, 2018 inspection of its Singapore facility. Read More
Phototherapy Developer Amiss on CAPA, Supplier Audits
Phototherapy developer National Biological Corp. fell short on several quality management systems, the FDA said following a Feb. 4-14 inspection of its Beachwood, Ohio plant. Read More
FDA Issues Alert for Beckman Coulter Blood Analyzers
The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts. Read More
Senator Demands Answers From Companies Over Duodenoscopes
Washington Democratic Sen. Patty Murray is demanding answers from the leaders of three device companies at the center of an ongoing FDA investigation of contaminated duodenoscopes that regulators worry are spreading deadly bugs. Read More
Canada Details New User Fees for Devices
Health Canada is increasing fees for device sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Read More
FDA Issues Final Guidance on Bench Performance Testing
The FDA issued final guidance on the information devicemakers should include in test report summaries, test protocols and complete test reports for non-clinical bench performance testing for premarket submissions. Read More
