Suntech Medical, Inc. - Inspection Records
Inspection records and compliance data for Suntech Medical, Inc. in Morrisville, North Carolina. 3 FDA inspections on record, last inspected May 22, 2024.
This profile covers Suntech Medical, Inc. based in Morrisville, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected April 25, 2012. Last inspected May 22, 2024.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1239175 |
| October 14, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 946903 |
| April 25, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 778375 |
No Form 483s, Warning Letters or EIRs on record.
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Name
Suntech Medical, Inc.
FEI Number
1036863
Address
5827 S Miami Blvd Ste 100, Morrisville, North Carolina 27560, United States
Country
United States
ID: 062f767b-5296-4e45-b54b-9b02b0fa4f3d