FDA Inspection
AtriCure, Inc.AtriCure, Inc. – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns AtriCure, Inc., with an inspection on March 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3723d12f-6410-4741-86fd-034ffd633e2b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1043957
- 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 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(e)Documentation
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Other FDA inspections of AtriCure, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 9, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 5, 2017 | Not classified | Cincinnati District Office | |
| August 24, 2017 | Not classified | Cincinnati District Office | |
| October 13, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AtriCure, Inc.
- FDA Inspection 1077020 - 2018-12-13
- FDA Inspection 1055553 - 2018-03-09
- FDA Inspection 1042648 - 2017-10-05
- FDA Inspection 1045711 - 2017-08-24
- FDA Inspection 990475 - 2016-10-13
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