Company
United StatesAdroit Medical Systems Inc, Loudon, TN – FDA Inspections
Inspection records and compliance data for Adroit Medical Systems Inc in Loudon, Tennessee. 5 FDA inspections on record, 2 Form 483s, last inspected July 11, 2025.
Company Profile
This profile covers Adroit Medical Systems Inc based in Loudon, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected January 28, 2010. Last inspected July 11, 2025.
Most cited issue areas
- DHR content1 inspection
- Documentation1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1278307 |
| April 11, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1085944 |
| July 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1017646 |
| January 23, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 765950 |
| January 28, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 642668 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Adroit Medical Systems Inc
FEI Number
1000111140
Address
1146 Carding Machine Rd, Loudon, Tennessee 37774, United States
Country
United States
ID: cb9c4b92-9482-4329-b9b4-823f58c7936c