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Fundus Photo, LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Fundus Photo, LLC has 0 FDA recalls, 4 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Fundus Photo, LLC" is on file.

What these totals cover: FDA records filed under the name "Fundus Photo, LLC" and its spelling variant "Fundus Photo".

Latest inspection: Mar 26, 2025 · NAI
Latest 510(k): Nov 17, 2010

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Fundus Photo, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

4 inspections from Jan 27, 2011 to Mar 26, 2025.

Date	Site	Product	Classification	FEI
Mar 26, 2025	Saint Louis, MO	Devices	No Action Indicated (NAI)	3007237389
Apr 12, 2022	Saint Louis, MO	Devices	Voluntary Action Indicated (VAI)	3007237389
Dec 21, 2016	Saint Louis, MO	Devices	No Action Indicated (NAI)	3007237389
Jan 27, 2011	Saint Louis, MO	Devices	Voluntary Action Indicated (VAI)	3007237389

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007237389	Saint Louis, MO	4	Mar 26, 2025

Recent 510(k) clearances

1 510(k) clearance on Nov 17, 2010.

K-Number	Device	Date
K093071	FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440	Nov 17, 2010

Fundus Photo, LLC and the FDA: common questions

Has Fundus Photo, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Fundus Photo, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Fundus Photo, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Fundus Photo, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Fundus Photo, LLC?

The most recent FDA inspection on file ended Mar 26, 2025 at Saint Louis, MO and was classified NAI. FDA has 4 inspections of Fundus Photo, LLC on file.

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