Failure to investigate complaints that certain devices did not meet specifications resulted in a Form 483 for Pacific Medical Group of San Clemente, Calif., following a Feb. 6 to March 14 FDA inspection.
The facility was cited in 2014 for failing to investigate returned fetal cable transducers and electrode cables that were not functioning. It also failed to investigate the root cause of the failure of the devices, which reoccurred after devices were returned to customers. At least 17 devices were reported as not functioning.
“Your firm failed to investigate the device malfunction, resulting in a use of the device [that] caused [a] burn or red mark on a patient,” the agency said, adding that the firm also failed to evaluate complaints for medical device reportability to the FDA.