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FUNDUS PHOTO FDA Inspection Record

FEI 3007237389 · Inspections, Form 483s, warning letters and import refusals

FUNDUS PHOTO is an FDA-registered facility (FEI 3007237389) located in Saint Louis, MO, US. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 26, 2025: No Action Indicated (NAI)
Inspections on record
4 (2 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 26, 2025No Action Indicated (NAI)Label to bear a unique device identifier (21 CFR 801.20(a))
Apr 12, 2022Voluntary Action Indicated (VAI)Lack of Written MDR Procedures (21 CFR 803.17)
Dec 21, 2016No Action Indicated (NAI)DHR - not or inadequately maintained (21 CFR 820.184)
Lack of or inadequate procedures (21 CFR 820.100(a))
DMR - not or inadequately maintained (21 CFR 820.181)
Maintained (21 CFR 820.198(e))
and 2 more
Jan 27, 2011Voluntary Action Indicated (VAI)DHR - not or inadequately maintained (21 CFR 820.184)
Lack of or inadequate procedures (21 CFR 820.100(a))
DMR - not or inadequately maintained (21 CFR 820.181)

FDA record score

4 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIApr 12, 20226 x 0.63.6
Inspection classified VAIJan 27, 201110 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Fundus Photo, LLC
Location
Saint Louis, MO (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.