The FDA issues a warning letter to Zynex Medical over its NexWave chronic pain device and IF8000 electrical stimulator, saying the company failed to adequately document adverse event reports and failed to tell the FDA about them in time.
The FDA sent a warning letter last month to Zynex Medical (OTC:ZYXI) flagging problems with how it handles adverse events with its NexWave and IF8000 chronic pain devices.
The federal watchdog agency said inspections conducted at Zynex’s Lone Tree, Colo., plant found that the company failed to establish adequate procedures for design inputs; failed to establish procedures for design verification; failed to establish a device master record; failed to maintain device history records with all the information required; failed to establish procedures for corrective and preventive actions and failed to establish procedures for internal audits, according to the June 27 letter.
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