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The inspector reviewed 123 complaints related to reports of infections and/or deaths for which the company had not opened corrective or preventive action files. Read More
Class II device manufacturer Arrowhead Dental was cited for failure to develop design control and medical device reporting procedures among other quality failures in a Form 483 issued following a December 2017 inspection of the firm’s Sandy, Utah facility. Read More
Smith & Nephew drew a Form 483 for multiple issues at its Memphis, Tennessee facility, including a faulty procedure for the control of nonconforming product and inadequate corrective and preventive action procedures. Read More
The FDA hit Pacific Hospital Supply, a manufacturer of disposable medical supplies including catheters, cannulae, tubing, and aspirators, with a warning letter after an inspection at the firm’s Miaoli, Taiwan facility revealed adulterated products. Read More
The FDA cited 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
Brazil’s National Surveillance Agency released an order mapping out the specific oversight roles for federal, state and local ANVISA branches for medical devices. Read More
The FDA 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
An FDA inspection of Digital Heat’s Tempe, Arizona facility conducted in December 2017 resulted in a nine-item Form 483 for failing to establish design procedures for the firm’s heated eye pad. Read More