FDA 483 - Sonablate Corp. - August 02, 2022

Sonablate Corporation in Charlotte, NC, was cited for six observations during an FDA inspection from July 21 to August 2, 2022. The inspection revealed significant deficiencies in design validation, complaint handling, quality audits, purchasing controls, and risk analysis. These issues indicate a systemic breakdown in the firm's quality system, particularly concerning device safety and regulatory reporting.