Elucid Bioimaging Inc.
Form 483 issued March 20, 2026 · Boston, Massachusetts
- Inspection
- Mar 18 – Mar 20, 2026
- Investigator
- James P. Finn
- Observations
- 1
- Pages
- 4
- FEI number
- 3013660213
In short: On March 20, 2026, FDA issued a Form 483 with 1 observation to Elucid Bioimaging Inc. in Boston, Massachusetts (FEI 3013660213) after an inspection that ran Mar 18 – Mar 20, 2026. The investigator was James P. Finn. The most-cited regulation is 21 CFR 8.2.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 8.2.2
Procedures for timely complaint handling have…
This inspection in context
James P. Finn
10 documents · 2019–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmElucid Bioimaging Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Elucid Bioimaging Inc.?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 8.2. The opening words of each observation are shown on this page.
Who inspected Elucid Bioimaging Inc.?
James P. Finn is named on this Form 483, for the inspection of Mar 18 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was Elucid Bioimaging Inc. inspected by FDA?
The inspection ran Mar 18 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for Elucid Bioimaging Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.