Whisper.ai, Inc.June 15, 2022

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

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Record Details

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.

Company: Whisper.ai, Inc.
Inspection Date: June 15, 2022
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
Person: Christopher S. Genther (investigator)

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ID · 530d8c07-899f-45b0-a3af-2ca9b953aba0