FDA sends warning letter to Nidek Medical Products
Device Regulation Alert: Safety, Compliance and Reimbursement News, May 9, 2009
Nidek Medical Products failed to properly document complaints about the company's oxygen concentrators, according to an FDA warning letter.
The FDA said the company failed to evaluate complaints properly to determine whether they should be reported to the FDA, and did not conduct adequate investigations of complaints, including one incident involving a patient’s death.
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