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Next year, the FDA will begin to require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent. 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
Validation procedures for production processes such as milling and lathe processes were found lacking during an October 2017 inspection of Mid South Precision’s Nashville, Tennessee facility. Read More
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