Company
United StatesAmtai Medical Equipment, INC, Raleigh, NC – FDA Inspections
Inspection records and compliance data for Amtai Medical Equipment, INC in Raleigh, North Carolina. 3 FDA inspections on record, 2 Form 483s, last inspected December 06, 2024.
Company Profile
This profile covers Amtai Medical Equipment, INC based in Raleigh, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected May 17, 2018. Last inspected December 6, 2024.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of procedures, or not maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 6, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1256165 |
| February 28, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1163282 |
| May 17, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1052245 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Amtai Medical Equipment, INC
FEI Number
3007591382
Address
5605 Primavera Ct, Raleigh, North Carolina 27616, United States
Country
United States
ID: 67a4f2b1-ac06-4ef3-8323-dabb818c3db5