FDA 483 - Talk To Me Technologies - October 26, 2021
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An FDA inspection of Talk To Me Technologies, a medical device manufacturer in Cedar Falls, IA, revealed three significant observations. The firm failed to include Unique Device Identifiers (UDI) or Universal Product Codes (UPC) in device history records and on labels. Additionally, the inspection found inadequate document control procedures, specifically lacking authorizing signatures and dates for key procedures like Complaint Handling, CAPA, and Recalls, and a failure to establish procedures for receiving purchased sub-assembly components.
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