# FDA 483 - Fitbit LLC - May 22, 2023

Source: https://www.globalkeysolutions.net/records/483/fitbit-llc/ae108e2a-3f4a-4c43-8d56-a216d6988d2e

> FDA 483 for Fitbit LLC on May 22, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fitbit LLC
- Inspection Date: 2023-05-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

Company: https://www.globalkeysolutions.net/companies/fitbit-llc/ee2a96e9-bac0-43bf-8d65-4763bdead5af

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