Fitbit LLCMay 22, 2023

FDA 483 - Fitbit LLC - May 22, 2023

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Record Details

An FDA inspection of Fitbit LLC in San Francisco, CA, revealed significant deficiencies in a non-significant risk device study. The firm failed to maintain IRB approval, keep accurate and complete records of adverse device effects, and ensure investigator compliance. These issues indicate serious non-compliance with regulations for investigational device exemptions.

Company: Fitbit LLC
Inspection Date: May 22, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
Person: Dustin R. Abaonza (investigator)

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ID · ae108e2a-3f4a-4c43-8d56-a216d6988d2e