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October 2017

No. 453


Full Issue of The GMP Letter in PDF Format

Download and view the full issue. Read More

FDA Launches Critical to Quality Pilot Program

The FDA rolled out its new Premarket Approval Application Critical to Quality pilot program, created to give PMA applicants the option to speak with the FDA on development of CtQ controls for their devices and to forego the standard PMA pre-approval inspection. Read More

EpiPen Manufacturer Bungled Response to Complaints of Failures, FDA Says

A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter. Read More

Cyber Risk Prompts Abbott Recall of 465K Pacemakers

In the first ever recall for a cybersecurity risk, Abbott recalled 465,000 implantable pacemakers for a firmware update to reduce the risk of unauthorized access. The update requires an in-person visit with a healthcare provider. Read More

Court Agrees to New Trial Over Negligence Claims Against DePuy

The Cook County Circuit Court revived a 2013 lawsuit against DePuy Orthopaedics and Premier Orthopaedics Sales alleging negligence in designing a hip replacement device. Read More

Protecting Devices From Cybersecurity Risks

With the recall of 465,000 Abbott pacemakers deemed at risk of getting hacked — marking the first ever device recall for a cybersecurity issue — it’s time for a deeper dive on how to protect your product from cyber risk. Read More

Warning Letter Roundup: FDA Targets Five Devicemakers

The FDA issued warning letters to five device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations. Read More

483 Roundup: FDA Cites Six Firms Over Complaints, Other Deficiencies

The FDA issued flagged six device manufacturers for issues ranging from responses to customer complaints to record-keeping. Read More

FDA Releases Final Guidance on Interoperable Devices

The FDA unveiled final recommendations for how medical devices should be designed to interact with other devices and IT systems. Read More

Brazil Revamps GMP Inspections to Improve Access to New Technologies

Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new technologies. Read More

FDA Officials Show Support for Risk-Based CAPA Strategy

FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Read More