FDA 483 - Sonavex, Inc. - February 06, 2025

Sonavex, Inc., a medical device manufacturer in Baltimore, MD, was cited with four observations during an FDA inspection. The firm failed to submit numerous Medical Device Reports for serious injuries and device malfunctions, and its complaint handling procedures were found to be inadequate, with many complaints left open for extended periods. Additionally, the inspection revealed deficiencies in CAPA effectiveness verification and a widespread lack of qualification for manufacturing equipment.