# FDA 483 - Fundus Photo, LLC - March 26, 2025

Source: https://www.keypedia.com/records/483/fundus-photo-llc/ac445ca5-fdc5-45b5-a64a-f9edc2f9254a

> FDA 483 for Fundus Photo, LLC on March 26, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fundus Photo, LLC
- Inspection Date: 2025-03-26
- Product Type: device
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Fundus Photo, LLC in Saint Louis, MO, revealed a significant issue regarding medical device labeling. The firm was cited for failing to apply unique device identifiers (UDI) to its Fundus Photo Digital Imaging System, a Class II medical device, on its hardware, software, and packaging. This indicates a non-compliance with UDI regulatory requirements.

## Related Documents

- [483 - 2022-04-12](https://www.keypedia.com/records/483/fundus-photo-llc/96cbd9bc-5fe7-4eaa-84a8-446321f60cc4)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/fundus-photo-llc/97a4ef58-6abc-477c-bfc1-4afc68d65667

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79