Company
United StatesEthicon, Inc., Cornelia, GA – FDA Inspections
Inspection records and compliance data for Ethicon, Inc. in Cornelia, Georgia. 7 FDA inspections on record, 2 Form 483s, last inspected September 27, 2018.
Company Profile
This profile covers Ethicon, Inc. based in Cornelia, Georgia, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 8, 2011. Last inspected September 27, 2018.
Most cited issue areas
- Statistical techniques - Lack of or inadequate procedures2 inspections
- Contamination control, Lack of or inadequate procedures1 inspection
- Documentation1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2018 | Not classified | Medical Devices & Rad Health | 1127087 |
| September 14, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1025149 |
| May 12, 2017 | Not classified | Medical Devices & Rad Health | 1022348 |
| April 24, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 924375 |
| August 30, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 849926 |
| February 27, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 770318 |
| September 8, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 747599 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ethicon, Inc.
FEI Number
1049223
Address
655 Ethicon Cir, Cornelia, Georgia 30531, United States
Country
United States
ID: ebaffaf1-02bb-4c94-a875-d3b954fcc2a7