Company
United StatesRaumedic Inc, Mills River, NC – FDA Inspections
Inspection records and compliance data for Raumedic Inc in Mills River, NC. 1 FDA inspection on record, 1 Form 483, last inspected March 13, 2026.
Company Profile
This profile covers Raumedic Inc based in Mills River, NC, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected March 13, 2026.
Most cited issue areas
- Procedures for validation of processes lack required elements1 inspection
- Production and service provision not adequate1 inspection
- Records of purchased product verification not maintained1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 13, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1308010 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Raumedic Inc
FEI Number
3012232668
Address
235 Broadpointe Dr, Mills River, NC 28759-4995, United States
Country
United States
ID: 46827904-c33b-454d-be9b-1aef01976ff2