FDA Inspection
Bonutti Research, Inc.Bonutti Research, Inc. – FDA Inspection, Dec 6, 2018
Record Details
This FDA Inspection record concerns Bonutti Research, Inc., with an inspection on December 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e9c5138a-0629-4ae5-a2e4-c71661aaa650
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1074197
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Bonutti Research, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 10, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bonutti Research, Inc.
- FDA Inspection 1080176 - 2018-12-06
- FDA Inspection 809901 - 2012-12-10
- FDA Inspection 657593 - 2010-04-13
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