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

The FDA conducted an inspection of Criticare Technologies, Inc. (FEI 3012238587) from March 21, 2024, to May 10, 2024, identifying that their patient monitors, including the nGenuity vital signs monitor, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Significant violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure (CTI 221 rev H) lacks sufficient detail for identifying nonconforming product causes, conducting investigations, taking appropriate actions, or verifying effectiveness. This is a repeat deficiency from a 2017 Warning Letter. The firm's response was inadequate, lacking details on corrective actions, documents, or a timeline. 2. **Failure to control device design (21 CFR 820.30(a))**: The design of nGenuity devices was not adequately controlled and documented. For example, a 2007 Hazard Analysis for the nGenuity CO2 Project did not identify hazards related to faulty internal ECG cables incorporated after 2015. The firm's response was