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.
BioMerieux received an FDA warning letter for its handling of complaints and nonconformances, including applying roughly 546 complaint description codes that are not defined in company documents. Read More
The FDA slapped Mani Hanoi, a Vietnam maker of surgical sutures with attached needles, with a warning letter for particle monitoring slips and other GMP issues. Read More
Devicemakers need to be vigilant against potential vulnerabilities embedded in medical device software as the FDA continues to formulate its cybersecurity strategy, a security expert warns. Read More
Labeling and packaging errors and software problems accounted for more than 40 percent of medical device recalls during the 2014 third quarter, according to a recent report by Stericycle. Read More
Verathon Medical ended an FDA inspection with a Form 483 for implementing changes to processes before appropriate verification and validation. Read More
Viramed Biotech, a German manufacturer of in vitro diagnostics, received a one-observation Form 483 related to an issue with its quality control procedure. Read More