FDA Inspection
Ethicon, Inc.Ethicon, Inc. – FDA Inspection, Feb 27, 2012
Record Details
This FDA Inspection record concerns Ethicon, Inc., with an inspection on February 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ethicon, Inc.
- Inspection Date
- February 27, 2012
- Product Type
- Devices
View Company Profile
ID · 69a1d2ec-56f7-4fdf-b9d6-97689fdc0c5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770318
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Ethicon, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2018 | Not classified | Atlanta District Office | |
| September 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2017 | Not classified | Atlanta District Office | |
| April 24, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 30, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ethicon, Inc.
- FDA Inspection 1127087 - 2018-09-27
- FDA Inspection 1025149 - 2017-09-14
- FDA Inspection 1022348 - 2017-05-12
- FDA Inspection 924375 - 2015-04-24
- FDA Inspection 849926 - 2013-08-30
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