Company
United StatesSureTek Medical, Greenville, SC – FDA Inspections
Inspection records and compliance data for SureTek Medical in Greenville, South Carolina. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 06, 2026.
Company Profile
This profile covers SureTek Medical based in Greenville, South Carolina, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 25, 2012. Last inspected March 6, 2026.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Equipment control activity documentation1 inspection
- Lack of or inadequate organizational structure1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 6, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1305850 |
| September 23, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 988803 |
| November 10, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 948473 |
| July 25, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 797481 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SureTek Medical
FEI Number
3005575604
Address
25B Maple Creek Cir, Greenville, South Carolina 29607, United States
Country
United States
ID: f2d5fd3e-1b81-411b-82bc-2e32339f47ec