RADIOMETER NEGLECTED COMPLAINTS ABOUT BLOOD GAS ANALYZER DEVICES
Radiometer America failed to address or investigate complaints about its blood gas analyzer devices, according to an FDA warning letter.
The FDA found several current good manufacturing practice violations in inspections earlier this year. Radiometer's devices are adulterated and misbranded, according to the agency's Oct. 12 warning letter, which was posted recently to the agency's website.
Radiometer did not investigate complaints about possible device failures, nor did it describe to the FDA how it would investigate a complaint, according to the warning letter. An agency inspector reviewed 18 complaints and found that nine had "incomplete failure investigations," the letter said.
Also, Radiometer failed to maintain adequate complaint files, the FDA said. Ten out of 12 closed complaint files the inspector saw were incomplete, according to the agency.