FDA 483 - Gobiquity, Inc - February 12, 2026
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An FDA inspection of Gobiquity, Inc. in Nashville, TN, revealed significant deficiencies in the firm's quality management system, particularly regarding the application of a risk-based approach. The inspection found inadequate controls over complaint handling, nonconforming product, corrective actions, data analysis, and design changes, especially concerning cybersecurity vulnerabilities. These issues led to product recalls and could adversely affect patient safety and data security.
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ID · 7f306094-d880-4f6a-bf73-7f98bc531833