FDA Inspection
Eagle Endoscopic, Inc.Eagle Endoscopic, Inc. – FDA Inspection, Apr 1, 2022
Record Details
This FDA Inspection record concerns Eagle Endoscopic, Inc., with an inspection on April 1, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eagle Endoscopic, Inc.
- Inspection Date
- April 1, 2022
- Product Type
- Devices
View Company Profile
ID · 400091e7-49d4-4004-a2f5-55b1673384bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1166292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Eagle Endoscopic, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 15, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Eagle Endoscopic, Inc.
- FDA Inspection 1005018 - 2017-03-14
- FDA Inspection 867333 - 2014-02-18
- FDA Inspection 699000 - 2010-11-15
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