# FDA 483 - Talk To Me Technologies - October 26, 2021

Source: https://www.keypedia.com/records/483/talk-to-me-technologies/06cfda88-f990-4b8f-b773-a267ca380d9e

> FDA 483 for Talk To Me Technologies on October 26, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Talk To Me Technologies
- Inspection Date: 2021-10-26
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2026-02-20](https://www.keypedia.com/records/483/talk-to-me-technologies/fa35855a-1cb7-49bc-ba1c-f00ae752ed36)

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/talk-to-me-technologies/76ffdeb8-c755-43f1-9be4-100c753ee74b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8