483
ZavationZavation – FDA 483, Jun 20, 2019
Record Details
An FDA inspection of Zavation Medical Products, LLC in Flowood, MS, identified a significant issue regarding the timely submission of Medical Device Reports (MDRs). The firm failed to submit MDRs within the required 30-day timeframe for device malfunctions that could potentially lead to death or serious injury if they recurred. This indicates a critical lapse in the company's post-market surveillance and reporting procedures.
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ID · 929978b5-d6f9-4db3-a4c8-21523c7bee66
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