FDA Inspection
Etymotic Research, Inc.Etymotic Research, Inc. – FDA Inspection, Jul 15, 2009
Record Details
This FDA Inspection record concerns Etymotic Research, Inc., with an inspection on July 15, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Etymotic Research, Inc.
- Inspection Date
- July 15, 2009
- Product Type
- Devices
View Company Profile
ID · 4fc39707-6774-4ca0-b808-bf468fcbe650
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 603528
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Etymotic Research, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2019 | Not classified | Chicago District Office | |
| November 2, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 9, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Etymotic Research, Inc.
- FDA Inspection 1143528 - 2019-08-14
- FDA Inspection 1031757 - 2017-11-02
- FDA Inspection 900647 - 2014-09-09
- FDA Inspection 650786 - 2010-03-02
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.