FDA Inspection
Eagle Endoscopic, Inc.Eagle Endoscopic, Inc. – FDA Inspection, Mar 14, 2017
Record Details
This FDA Inspection record concerns Eagle Endoscopic, Inc., with an inspection on March 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b992c0f7-2925-468e-bc3c-53a72224a4b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005018
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Eagle Endoscopic, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2022 | 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 1166292 - 2022-04-01
- FDA Inspection 867333 - 2014-02-18
- FDA Inspection 699000 - 2010-11-15
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