FDA 483 - Sotera Wireless, Inc. - June 19, 2026

An FDA inspection of Sotera Wireless, Inc., a Class II medical device manufacturer in San Diego, CA, revealed two significant observations. The firm failed to provide justification for not reporting a correction or removal action to the FDA, specifically regarding a complaint about their Visi Mobile Monitoring System. Additionally, procedures for corrective and preventive actions were found to be inadequately established, with an open CAPA not being investigated or closed in a timely manner.