# FDA 483 - Prove Labs Inc. - April 17, 2024

Source: https://www.keypedia.com/records/483/prove-labs-inc/e7dbe57b-6f30-403c-b477-5d65dc910194

> FDA 483 for Prove Labs Inc. on April 17, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prove Labs Inc.
- Inspection Date: 2024-04-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Prove Labs Inc. in Brooklyn, NY, was inspected by the FDA, resulting in six observations primarily concerning inadequate quality system procedures for their medical device software. The inspection revealed deficiencies in design change documentation, lack of written procedures for MDRs, complaint handling, quality audits, and management reviews. Additionally, the firm failed to obtain a Unique Device Identifier for its FitCam Health app.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/prove-labs-inc/b7610a54-1c92-4285-936e-9a22785962bf

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961