Company
United StatesEmage Medical LLC, Charlotte, NC – FDA Inspections
Inspection records and compliance data for Emage Medical LLC in Charlotte, North Carolina. 3 FDA inspections on record, 2 Form 483s, last inspected September 26, 2024.
Company Profile
This profile covers Emage Medical LLC based in Charlotte, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 20, 2012. Last inspected September 26, 2024.
Most cited issue areas
- Lack of or inadequate procedures - Acceptance activities2 inspections
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Servicing - Lack of or inadequate procedures2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1229203 |
| April 4, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1201740 |
| June 20, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 787780 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Emage Medical LLC
FEI Number
3007645866
Address
7515 Robin Crest Rd, Charlotte, North Carolina 28226, United States
Country
United States
ID: 74a96d3c-b7c3-4513-8a90-59ca8bddc5bf