FDA Inspection
Etymotic Research, Inc.Etymotic Research, Inc. – FDA Inspection, Mar 2, 2010
Record Details
This FDA Inspection record concerns Etymotic Research, Inc., with an inspection on March 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Etymotic Research, Inc.
- Inspection Date
- March 2, 2010
- Product Type
- Devices
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ID · cbcf91c9-99f7-4a5c-a7a4-9fa45427dac5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 650786
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(a)(1)Statistical methodology
- 21 CFR 820.20Management responsibility
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)(1)Procedure for analysis of data sources
- 21 CFR 820.184(a)DHR content - manufacturing dates
- 21 CFR 820.184(e)ID label, labeling
Showing 10 of 11 citations.
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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 |
| July 15, 2009 | 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 603528 - 2009-07-15
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