Company
United StatesSpineCraft, LLC., Westmont, IL – FDA Inspections
Inspection records and compliance data for SpineCraft, LLC. in Westmont, Illinois. 5 FDA inspections on record, last inspected March 22, 2024.
Company Profile
This profile covers SpineCraft, LLC. based in Westmont, Illinois, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected April 12, 2012. Last inspected March 22, 2024.
Most cited issue areas
- Adverse events--all info not in file1 inspection
- Complaints1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1233747 |
| December 13, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1074762 |
| November 14, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1073334 |
| August 18, 2016 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 985974 |
| April 12, 2012 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 777309 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SpineCraft, LLC.
FEI Number
3004717358
Address
777 Oakmont Ln Ste 200, Westmont, Illinois 60559, United States
Country
United States
ID: 1f8afee0-4555-47a4-93df-1b10a279b5bc