Sunnex, LLC
FDA inspection history in Charlotte, North Carolina, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Charlotte, North Carolina.
- 2022One Form 483, at Charlotte, North Carolina.
- 2022The longest 483 on file: 11 observations over 11 pages at Charlotte, North Carolina.
Cited most
Across all Sunnex observations on file
- 21 CFR 820.30(b)Design controls6
- 21 CFR 820.200(b)Servicing2
- 21 CFR 8201
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(c)Complaint files1
The complete Sunnex file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Charlotte, North Carolina
Two Form 483s · 2019 to 2022 · 13 observations
Latest: Form 483, Feb 18, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-18 | 483 Form 483 | Charlotte, North Carolina | 11 | $99 |
| 2019-07-03 | 483 Form 483 | Charlotte, North Carolina | 2 | $99 |
Investigators on these documents
FEI number 1000583780 · most recent document Feb 18, 2022
About Sunnex, LLC
How many FDA Form 483s has Sunnex, LLC received?
FDA Intel has 2 Form 483s on file for Sunnex, LLC; the most recent is dated Feb 18, 2022.
When was Sunnex, LLC last inspected by FDA?
The most recent FDA inspection document on file for Sunnex, LLC is a Form 483 dated Feb 18, 2022, for the site in Charlotte, North Carolina.
What did FDA cite at Sunnex, LLC?
The regulations cited most in the observations on file for Sunnex, LLC are 21 CFR 820.30(b) (Design controls), 6 times; 21 CFR 820.200(b) (Servicing), 2 times; 21 CFR 820, 1 time.