483
Talk To Me TechnologiesTalk To Me Technologies – FDA 483, Feb 20, 2026
Record Details
An FDA inspection of Talk To Me Technologies in Cedar Falls, IA, a manufacturer of Class II communication aids, revealed a significant issue with their complaint handling procedures. The firm's complaint procedure was found to be inadequately established, failing to include required elements for complaint documentation, specifically lacking device name and unique device identifier for critical complaints involving patients unable to communicate.
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ID · b261f1f7-28a2-4b51-8bf8-b27133ccc042
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