FDA 483 - Linde Gas & Equipment Inc

Linde Gas & Equipment Inc, located in Livingston, TN, underwent an FDA inspection from July 15 to July 25, 2025. The inspection revealed significant compliance issues with the firm's corrective and preventive action (CAPA) procedures, particularly concerning the NOxBOXi, a Class II medical device used for nitric oxide therapy in neonates.

Key violations include:

1. **Inadequate Corrective Actions**: The firm failed to effectively address recurring device malfunctions, specifically NO2 sensor failures, which could lead to incorrect clinical decisions impacting neonatal care. Despite identifying a software discrepancy as the root cause, the corrective measures taken, such as widening error tolerances, were insufficient and did not resolve the underlying software design issues.

2. **Off-Label Use**: The NOxBOXi was reported to be used off-label, resulting in adverse events, including one death and one serious injury. The firm's response, focusing on revising clinician training materials, was deemed inadequate to prevent further off-label use.

3. **Dose Fluctuations**: The device exhibited dose fluctuations during High Frequency Jet Ventilation, compromising treatment efficacy. The firm communicated this issue to the manufacturer but took no further corrective actions, despite acknowledging a related adverse event.

4. **Internal Fault Alerts**: Devices issued alerts during therapy, potentially leading to oxygen desaturation in neonates. Although a software solution was identified, its implementation was delayed due to resource constraints, leaving the issue unresolved.

The FDA requires Linde Gas & Equipment Inc to conduct comprehensive internal audits and implement effective corrective actions to address these critical safety concerns, ensuring compliance with quality system requirements and safeguarding patient health.