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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
The FDA slapped Sollentuna, Sweden-based MKL Diagnostics with a warning letter for failing to have a design control procedure for its Phadebact test kits. Read More
Cook Medical is under pressure from the FDA to fix sweeping quality problems at its Indiana facility relating to how the devicemaker addressed more than 735,000 manufacturing nonconformances over a two-year period. Read More
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. Read More
Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More
Medtronic cleared the final regulatory hurdles ahead of its planned $43 billion merger with Covidien, getting a positive nod from antitrust bodies in China and South Korea. Read More