The FDA cited Advanced Monitored Caregiving after a March inspection of the devicemaker’s New York facility turned up problems with procedures for device acceptance and evaluation of potential suppliers.
The agency investigator found the acceptance procedures for several devices did not include instructions for device pairing and data transmission testing. The final testing acceptance records presented during the inspection did not indicate if the devices transmitted accurate readings and they did not document the equipment used to conduct the testing.
The company also failed to properly document its evaluation of potential suppliers and it did not produce documentation that demonstrated proper assessment of vendors as detailed in its written procedures. In addition, the facility did not obtain approval signatures for software change testing documentation ahead of the updates.