FDA Inspection
Wellstar Kennestone HospitalWellstar Kennestone Hospital – FDA Inspection, Jun 11, 2012
Record Details
This FDA Inspection record concerns Wellstar Kennestone Hospital, with an inspection on June 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Wellstar Kennestone Hospital
- Inspection Date
- June 11, 2012
- Product Type
- Biologics
View Company Profile
ID · f86e5bd7-eeae-411d-b659-32efa26edaf4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 786088
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.140(a)Establishment of spec., standards, and test procedures
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Wellstar Kennestone Hospital
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 6, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 21, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 16, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 30, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Wellstar Kennestone Hospital
- FDA Inspection 1049012 - 2018-03-22
- FDA Inspection 964818 - 2016-04-06
- FDA Inspection 891691 - 2014-08-21
- FDA Inspection 701784 - 2010-12-16
- FDA Inspection 601769 - 2009-07-30
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