Company
United StatesSolTek Spine, LLC., Plano, TX – FDA Inspections
Inspection records and compliance data for SolTek Spine, LLC. in Plano, Texas. 2 FDA inspections on record, last inspected May 05, 2015.
Company Profile
This profile covers SolTek Spine, LLC. based in Plano, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 28, 2012. Last inspected May 5, 2015.
Most cited issue areas
- Storage temperatures recorded, maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 5, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 924718 |
| June 28, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 788375 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SolTek Spine, LLC.
FEI Number
3008531620
Address
5160 Village Creek Dr Ste 300, Plano, Texas 75093, United States
Country
United States
ID: 8cccdcf0-3872-4403-98f6-85115e7bec86