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The number of devicemakers that received warning letters from the U.S. Food and Drug Administration following quality system inspections decreased 12 percent in 2013, compared with the previous year — the first decline since 2009. Read More
Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows. Read More
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
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