ESN Medical Inc
Form 483 issued September 5, 2025 · Charlotte, North Carolina
- Inspection
- Sep 3 – Sep 5, 2025
- Investigator
- Gamal A. Norton
- Observations
- 1
- Pages
- 3
- FEI number
- 1038963
In short: On September 5, 2025, FDA issued a Form 483 with 1 observation to ESN Medical Inc in Charlotte, North Carolina (FEI 1038963) after an inspection that ran Sep 3 – Sep 5, 2025. The investigator was Gamal A. Norton. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The design was not validated under actual…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmESN Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ESN Medical Inc?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected ESN Medical Inc?
Gamal A. Norton is named on this Form 483, for the inspection of Sep 3 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was ESN Medical Inc inspected by FDA?
The inspection ran Sep 3 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
How do I get the full Form 483 for ESN Medical 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.