FDA 483 - Criticare Technologies, Inc. - May 10, 2024

During an FDA inspection from March 21 to May 10, 2024, Criticare Technologies, Inc. in Warwick, RI, received a Form FDA 483 outlining ten significant observations related to its compliance with medical device quality system regulations. The inspection identified critical deficiencies, many of which were repeat observations from previous inspections.Primary violations included inadequate procedures for corrective and preventive actions (CAPA), with many CAPAs incomplete or overdue, failing to address issues like faulty display cables leading to 217 complaints or CO₂ module malfunctions. Complaint handling was also inadequate, with 45 reviewed complaints lacking proper investigation, including instances of inaccurate readings or devices shutting off during surgery.The firm's risk analysis was deemed insufficient, lacking a current risk management plan and failing to identify known risks for products like the nGenuity monitor. Design verification and validation studies for pulse oximetry accuracy and device performance were also found inadequate. Further issues involved insufficient control of nonconforming products, lack of documented supplier approval, missing device information in the Global Unique Device Identification Database (GUDID), inadequate acceptance activity procedures, and undocumented personnel training.These observations indicate a need for comprehensive improvements to Criticare Technologies’ quality system. The company has largely "promised to correct" these issues, signifying a commitment to address the identified non-conformities.