Company
United StatesOsteoSymbionics LLC, Cleveland, OH – FDA Inspections
Inspection records and compliance data for OsteoSymbionics LLC in Cleveland, Ohio. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 29, 2017.
Company Profile
This profile covers OsteoSymbionics LLC based in Cleveland, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 3, 2010. Last inspected March 29, 2017.
Most cited issue areas
- Calibration procedures - content1 inspection
- Documentation1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1006041 |
| June 25, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 836437 |
| November 3, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 752758 |
| November 3, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 696938 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
OsteoSymbionics LLC
FEI Number
3007223102
Address
1768 E 25th St, Cleveland, Ohio 44114, United States
Country
United States
ID: 4aecdd20-2102-4403-ab02-7041d9a6d233