Company
United StatesBonutti Research, Inc., Effingham, IL – FDA Inspections
Inspection records and compliance data for Bonutti Research, Inc. in Effingham, Illinois. 4 FDA inspections on record, 1 Form 483, last inspected December 06, 2018.
Company Profile
This profile covers Bonutti Research, Inc. based in Effingham, Illinois, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected April 13, 2010. Last inspected December 6, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
- Training - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 6, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1080176 |
| December 6, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1074197 |
| December 10, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 809901 |
| April 13, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 657593 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bonutti Research, Inc.
FEI Number
1000143873
Address
2600 S Raney St, Effingham, Illinois 62401, United States
Country
United States
ID: 6cd49c41-845b-447c-8b23-90b164be5f79