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June 2019

No. 473


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