Company
United StatesSunnex, LLC, Charlotte, NC – FDA Inspections
Inspection records and compliance data for Sunnex, LLC in Charlotte, North Carolina. 7 FDA inspections on record (1 OAI), 2 Form 483s, last inspected February 27, 2023.
Company Profile
This profile covers Sunnex, LLC based in Charlotte, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 29, 2010. Last inspected February 27, 2023.
Most cited issue areas
- DMR - not or inadequately maintained3 inspections
- Document review, approval by designated individual2 inspections
- Lack of or inadequate final acceptance procedures2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 27, 2023 | Not classified | Medical Devices & Rad Health | 1198971 |
| February 18, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1162566 |
| July 3, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1095148 |
| July 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1017642 |
| February 18, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 916882 |
| July 30, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 792958 |
| November 29, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 699894 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sunnex, LLC
FEI Number
1000583780
Address
8001 Tower Point Dr, Charlotte, North Carolina 28227, United States
Country
United States
ID: 8a909b31-6bcb-4a15-9c5e-c1f91bb4f858