FDA 483 - Criticare Technologies, Inc. - March 29, 2017

Criticare Technologies Inc. in North Kingstown, RI, received a Form FDA 483 with 13 observations following an inspection from March 6-29, 2017. The inspection revealed significant deficiencies across multiple quality system areas, including failures in medical device reporting, complaint handling, CAPA procedures, nonconforming product control, and various aspects of manufacturing and quality control. These issues indicate a systemic lack of adequate procedures and documentation for ensuring device quality and safety.