Sunnex, LLC
Form 483 issued February 18, 2022 · Charlotte, North Carolina
- Inspection
- Feb 9 – Feb 18, 2022
- Investigator
- Gamal A. Norton
- Observations
- 11
- Pages
- 11
- FEI number
- 1000583780
In short: On February 18, 2022, FDA issued a Form 483 with 11 observations to Sunnex, LLC in Charlotte, North Carolina (FEI 1000583780) after an inspection that ran Feb 9 – Feb 18, 2022. The investigator was Gamal A. Norton. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 7 of 11 observations.
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 identification of the design, method(s), the date and the individual(s) performing…
- 03
Procedures for design transfer have…
- 04
Design plans that describe or reference the design and development activities and define responsibility for implementation…
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 11 observations on this Form 483, mostly about design controls, production & process controls and records & documents. 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 Feb 9 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Sunnex, LLC inspected by FDA?
The inspection ran Feb 9 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
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.