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Sponsors of medical devices supplied in Australia would be required to ensure their devices carry UDIs and that relevant information be entered into the Australian UDI database. Read More
Contract manufacturer Thatcher Company failed to exercise appropriate controls over computers and related systems to assure that changes in production were only instituted by authorized personnel, FDA inspectors found during a Sept. 10 to Sept. 18 inspection of the firm’s Salt Lake City, Utah, facility. Read More
Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual Properties’ Irvine, Calif. facility. Read More
FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Read More
International medical device associations rejected a recent report by the International Consortium of Investigative Journalists (ICIJ), which pointed to inadequate oversight of devices globally. Read More
The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing and installation requirements for “electronic products.” Read More
Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed the problems with design control procedures, CAPA procedures or complaints. Read More