We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Flotec was hit with a Form 483 for inadequate reviews of nonconforming products, poorly documented corrective action procedures, and inadequate complaint reviews. Read More
Germany’s Biotronik received a warning letter for inadequate process validation procedures, supplier selection procedures, and other violations. Read More
Korea-based Neo Vision received a warning letter for failing to establish proper design controls, monitor production processes, maintain device history records, and other violations. Read More
Heater cooler units used in cardiopulmonary bypass and extracorporeal membrane oxygenation can generate potentially infectious aerosols containing a range of harmful bacteria, some of which can be fatal, according to an ongoing UK investigation. Read More
The FDA slapped medical device manufacturer XZeal Technologies with a Form 483, citing issues with reporting procedures and design validation. Read More