Warning Letter Roundup & Recap – Dec. 19, 2017
US FDA asks syringe-maker Nurse Assist to hire a consultant to audit its manufacturing and quality systems, and targets another firm for marketing Zika virus tests without pre-market approval or clearance in two device-related warning letters posted this week.
You may also be interested in...
The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.
The US agency says its medical device program is in desperate need of an information technology upgrade, noting that its outdated IT systems, tools and approaches could leave it flat-footed when dealing with cybersecurity threats and ever-evolving medtech. That’s why the FDA is asking Congress for $18m to tackle the IT sore spot.
FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events
The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.