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The FDA citedd ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California. Read More
The FDA dinged ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California. Read More
In a rare exception to the FDA’s normal practice, the agency posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More
A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures. Read More
The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Read More
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead test results associated with Magellan’s LeadCare test systems. Read More
Light Age, a New Jersey-based manufacturer of Class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Read More