# FDA 483 - Caliber Imaging and Diagnostics, Inc. - February 06, 2025

Source: https://www.keypedia.com/records/483/caliber-imaging-and-diagnostics-inc/49cf0575-7cac-48f3-a78a-ddc34ae15b10

> FDA 483 for Caliber Imaging and Diagnostics, Inc. on February 06, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Caliber Imaging and Diagnostics, Inc.
- Inspection Date: 2025-02-06
- Product Type: device
- Office Name: New York District Office
- Summary: Caliber Imaging and Diagnostics, Inc. in Rochester, NY, was inspected by the FDA from February 4-6, 2025. The inspection revealed one observation concerning the firm's quality system. Specifically, the company failed to establish procedures for corrective and preventive actions, neglecting to investigate the root cause of non-conformities for its VivaScope 3000 device.

## Related Documents

- [483 - 2019-10-10](https://www.keypedia.com/records/483/caliber-imaging-and-diagnostics-inc/bb1ff60b-6139-4d0c-973c-0ae85ba8ac04)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/caliber-imaging-and-diagnostics-inc/d01f5ec8-20b5-46b3-b18e-ec8390c06953

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d