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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
The FDA inspector said the firm failed to establish a design history file to demonstrate that the design was developed to comply with 21 CFR Part 820. Read More
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