EUSA Global, LLC
Form 483 issued February 6, 2026 · Medley, Florida
- Inspection
- Feb 2 – Feb 6, 2026
- Investigator
- Gisselle I. Sensebe
- Observations
- 2
- Pages
- 4
- FEI number
- 3007532396
In short: On February 6, 2026, FDA issued a Form 483 with 2 observations to EUSA Global, LLC in Medley, Florida (FEI 3007532396) after an inspection that ran Feb 2 – Feb 6, 2026. The investigator was Gisselle I. Sensebe. The most-cited regulation is 21 CFR 4.2 (how does FDA define key terms and phrases in this subpart?).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 4.2.1
The quality management system documentation does not adequately include documents and records to ensure effective planning…
- 02
EMPLOYEEfS) SIGNATURE DATE…
This inspection in context
Gisselle I. Sensebe
3 documents · 2022–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmEUSA Global, LLC history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at EUSA Global, LLC?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 4.2 (how does FDA define key terms and phrases in this subpart?). The opening words of each observation are shown on this page.
Who inspected EUSA Global, LLC?
Gisselle I. Sensebe is named on this Form 483, for the inspection of Feb 2 – Feb 6, 2026. Each investigator has a profile showing what they cite most.
When was EUSA Global, LLC inspected by FDA?
The inspection ran Feb 2 – Feb 6, 2026, and the Form 483 is dated February 6, 2026.
How do I get the full Form 483 for EUSA Global, LLC?
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.