Hoggan Scientific LLC was hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues.…
Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Source: The GMP Letter
CryoSurgery Inc. landed a Form 483 for poorly documented acceptance activities and inadequate procedures for ensuring the quality of received products. Source: The GMP Letter
Manufacturing-related provisions in the recently enacted 21st Century Cures Act establish a program for “breakthough” devices, exempt some categories of medical software from regulation as a medical device, and require…
Aesculap Inc. was cited in a Form 483 for neglecting to file timely medical device reportable (MDR) events and establish timely corrective and preventive actions in response to complaints. Source:…
The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Source: The GMP…
In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Source: The GMP Letter
B. Braun Medical has agreed to resolve criminal liability allegations by paying $4.8 million in penalties and forfeiting an additional $4 million in restitution for selling contaminated pre-filled saline flush…
The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Source: The GMP Letter
Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Source: The GMP Letter