483
Sonic Manufacturing Technologies, Inc.FDA 483 - Sonic Manufacturing Technologies, Inc. - March 07, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · f6bcfb8d-578d-43b9-add3-2d1f0a17871b