FDA SAYS COMPANY FAILED TO INVESTIGATE DEVICE COMPLAINTS
HemoSense's medical devices are adulterated due to current good manufacturing practice violations regarding its complaint handling and investigating system, an FDA warning letter said.
During facility inspections May 15-July 13, 2006, an FDA investigator found problems with HemoSense's INRatio INR System, an in vitro diagnostic system that measures how long it takes blood to clot.
The company responded to the agency's Form 483, but all of its responses were inadequate, according to the Nov. 29, 2006, FDA letter, posted recently to the agency's website.
The agency did not accept most of the responses because the corrective and preventive actions taken were not complete, the agency said, adding that it would review the responses during a follow-up investigation.