FDA 483 - Criticare Technologies, Inc. - June 11, 2018

Criticare Technologies Inc. in North Kingstown, RI, was issued a Form FDA 483 with five repeat observations following an inspection from May 31 to June 11, 2018. The inspection revealed significant and persistent deficiencies in the firm's quality system. These issues include inadequate procedures for corrective and preventive actions, complaint handling, nonconforming product disposition, servicing activities, and employee training.