Company
United StatesNovaBone Products LLC, Alachua, FL – FDA Inspections
Inspection records and compliance data for NovaBone Products LLC in Alachua, Florida. 2 FDA inspections on record, last inspected March 20, 2015.
Company Profile
This profile covers NovaBone Products LLC based in Alachua, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 3, 2011. Last inspected March 20, 2015.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 20, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 919526 |
| November 3, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 752755 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
NovaBone Products LLC
FEI Number
3003768919
Address
13510 Nw Us Highway 441 Ste 600, Alachua, Florida 32615, United States
Country
United States
ID: 5923b259-7787-4dfc-88fd-5cb39f8d3ba9