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IRAY IMAGING LLC — FDA Facility Profile

FEI 3030898585

IRAY IMAGING LLC is an FDA-registered facility (FEI 3030898585) located in Solon, OH, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Oct 24, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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
Oct 24, 2025Voluntary Action Indicated (VAI)Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))

Facility details

Company
IRAY IMAGING LLC
Location
Solon, OH (US)
Source
device

FDA data resources

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