# FDA 483 - Fundus Photo, LLC - April 12, 2022

Source: https://www.globalkeysolutions.net/records/483/fundus-photo-llc/96cbd9bc-5fe7-4eaa-84a8-446321f60cc4

> FDA 483 for Fundus Photo, LLC on April 12, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fundus Photo, LLC
- Inspection Date: 2022-04-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Fundus Photo, LLC, a medical device manufacturer in Saint Louis, MO, from April 7-12, 2022, identified one significant observation. The firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures. This indicates a deficiency in their quality system regarding adverse event reporting.

## Related Documents

- [483 - 2025-03-26](https://www.globalkeysolutions.net/records/483/fundus-photo-llc/ac445ca5-fdc5-45b5-a64a-f9edc2f9254a)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8