Company
United StatesComfortland Medical, Inc., Mebane, NC – FDA Inspections
Inspection records and compliance data for Comfortland Medical, Inc. in Mebane, North Carolina. 2 FDA inspections on record, 1 Form 483, last inspected June 12, 2026.
Company Profile
This profile covers Comfortland Medical, Inc. based in Mebane, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 26, 2016. Last inspected June 12, 2026.
Most cited issue areas
- Complaint handling records not maintained1 inspection
- Control over outsourced processes not proportionate to risk1 inspection
- Design and development files not maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 12, 2026 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1321728 |
| September 26, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 987385 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Comfortland Medical, Inc.
FEI Number
3008724689
Address
709 A O Smith Rd, Mebane, North Carolina 27302, United States
Country
United States
ID: 2289b15e-d384-4916-8d26-ab5859bc84e8