# FDA 483 - Whisper.ai, Inc. - June 15, 2022

Source: https://www.keypedia.com/records/483/whisperai-inc/530d8c07-899f-45b0-a3af-2ca9b953aba0

> FDA 483 for Whisper.ai, Inc. on June 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Whisper.ai, Inc.
- Inspection Date: 2022-06-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Whisper.ai, Inc. in San Francisco, CA, was inspected by the FDA from June 13-15, 2022. The inspection revealed that the firm's procedures for receiving, reviewing, and evaluating complaints were not adequately established. Specifically, the complaint handling process lacked clear definitions for responsibilities in documenting complainant contact information.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/whisperai-inc/f8691bb8-7d25-4407-aed0-71a456c44e33

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b