Company
United StatesWellstar Kennestone Hospital, Marietta, GA – FDA Inspections
Inspection records and compliance data for Wellstar Kennestone Hospital in Marietta, Georgia. 6 FDA inspections on record, last inspected March 22, 2018.
Company Profile
This profile covers Wellstar Kennestone Hospital based in Marietta, Georgia, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected July 30, 2009. Last inspected March 22, 2018.
Most cited issue areas
- Biological product deviation report1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Establishment of spec., standards, and test procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2018 | NAI | Biologics · Blood and Blood Products | 1049012 |
| April 6, 2016 | NAI | Biologics · Blood and Blood Products | 964818 |
| August 21, 2014 | NAI | Biologics · Blood and Blood Products | 891691 |
| June 11, 2012 | VAI | Biologics · Blood and Blood Products | 786088 |
| December 16, 2010 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 701784 |
| July 30, 2009 | NAI | Biologics · Blood and Blood Products | 601769 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Wellstar Kennestone Hospital
FEI Number
1072965
Address
677 Church St Ne, Marietta, Georgia 30060, United States
Country
United States
ID: b2049938-23ca-4019-bc48-cdb26b61504e