FDA Inspection
Ethicon, Inc.Ethicon, Inc. – FDA Inspection, Apr 24, 2015
Record Details
This FDA Inspection record concerns Ethicon, Inc., with an inspection on April 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ethicon, Inc.
- Inspection Date
- April 24, 2015
- Product Type
- Devices
View Company Profile
ID · f0cd1ba7-a01b-406b-818f-6806032386f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 924375
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 | |
| August 30, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2012 | 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 849926 - 2013-08-30
- FDA Inspection 770318 - 2012-02-27
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.