FDA 483 - Sonic Manufacturing Technologies, Inc. - March 07, 2025

An FDA inspection of Sonic Manufacturing Technologies, Inc. in Fremont, CA, revealed significant deficiencies in the firm's complaint handling system. The company failed to adequately maintain complaint files, lacking documentation for how and when complaints were received. Additionally, the firm did not define clear parameters for acknowledging, responding to, or assessing complaints, indicating a breakdown in their corrective action process.