FDA 483 - Linde Gas & Equipment Inc - July 25, 2025

**FDA 483 Summary: Linde Gas & Equipment Inc**

**Inspection Dates:** July 15-25, 2025 **Location:** Livingston, TN **FEI Number:** 3012160128 **Report Issued to:** John E. Holland, Director of Healthcare Operations

**Key Violations:**

1. **Corrective and Preventive Action (CAPA) Deficiencies:** Linde Gas & Equipment Inc failed to adequately establish procedures for corrective and preventive actions, particularly concerning the NOxBOXi, a Class II medical device. The device is crucial for delivering and monitoring nitric oxide therapy in neonates.

2. **Recurrent Device Malfunctions:** The firm has not effectively addressed recurring malfunctions, such as NO2 sensor failures, which can lead to inadequate nitric oxide delivery and undetected NO2 toxicity. These issues are linked to software discrepancies.

3. **Off-label Use:** Despite identifying off-label use of the NOxBOXi, which resulted in adverse events including one death, the firm’s corrective actions, such as reviewing clinician training materials, were deemed insufficient.

4. **Dose Fluctuations:** The NOxBOXi exhibited dose fluctuations during High Frequency Jet Ventilation, compromising treatment efficacy. The firm communicated this issue to the manufacturer but did not implement further corrective actions.

5. **Internal Fault Alerts:** Devices issued alerts during therapy, disrupting treatment and causing oxygen desaturation in neonates. Although a software solution was identified, implementation has been delayed due to resource constraints.

**Regulatory Framework:** The firm is responsible for compliance with FDA quality system requirements, which mandate internal audits and timely corrective actions to address any violations.

**Required Actions:** Linde Gas & Equipment Inc must develop and implement effective corrective actions to address the identified deficiencies, particularly focusing on software improvements and ensuring compliance with device specifications to mitigate risks to patient safety.