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ELUCID BIOIMAGING — FDA Facility Profile

FEI 3013660213

ELUCID BIOIMAGING is an FDA-registered facility (FEI 3013660213) located in Boston, MA, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 20, 2026: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 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 20, 2026No Action Indicated (NAI)Complaint handling procedures not documented (ISO 13485:2016 Clause 8.2.2)
Apr 2, 2019Voluntary Action Indicated (VAI)Quality audits - auditor independence (21 CFR 820.22)
Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
Design review - documentation (21 CFR 820.30(e))
Design verification - documentation (21 CFR 820.30(f))
and 1 more

Facility details

Company
Elucid Bioimaging Inc.
Location
Boston, MA (US)
Source
device

FDA data resources

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