483
Talk To Me TechnologiesFDA 483 - Talk To Me Technologies - February 20, 2026
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 Talk To Me Technologies, a manufacturer of Class II communication aids in Cedar Falls, IA, identified one significant observation. The firm's complaint handling procedures were found to be inadequate, specifically lacking requirements for recording essential device identification information for critical complaints involving patients unable to communicate.
Open in Dashboard
ID · fa35855a-1cb7-49bc-ba1c-f00ae752ed36