Sunnex, LLC
Form 483 issued July 3, 2019 · Charlotte, North Carolina
- Inspection
- Jun 25 – Jul 3, 2019
- Investigator
- Gamal A. Norton
- Observations
- 2
- Pages
- 8
- FEI number
- 1000583780
In short: On July 3, 2019, FDA issued a Form 483 with 2 observations to Sunnex, LLC in Charlotte, North Carolina (FEI 1000583780) after an inspection that ran Jun 25 – Jul 3, 2019. 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
2 of 2 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (1×) · 820.30(f) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The design was not validated under defined operating conditions and using initial production units, lots or…
- 02
The design verification results, including, were not documented in…
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 firmSunnex, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Sunnex, LLC?
FDA listed 2 observations 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 Sunnex, LLC?
Gamal A. Norton is named on this Form 483, for the inspection of Jun 25 – Jul 3, 2019. Each investigator has a profile showing what they cite most.
When was Sunnex, LLC inspected by FDA?
The inspection ran Jun 25 – Jul 3, 2019, and the Form 483 is dated July 3, 2019.
How do I get the full Form 483 for Sunnex, 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.