FDA Inspection
Carolinas Medical CenterCarolinas Medical Center – FDA Inspection, Aug 16, 2013
Record Details
This FDA Inspection record concerns Carolinas Medical Center, with an inspection on August 16, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Carolinas Medical Center
- Inspection Date
- August 16, 2013
- Product Type
- Biologics
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ID · ae05c281-e9d5-4a9a-991d-3ab9bf36afe4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844945
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Carolinas Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 7, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 6, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 11, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 21, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Carolinas Medical Center
- FDA Inspection 1324548 - 2026-06-24
- FDA Inspection 1246462 - 2024-08-07
- FDA Inspection 1041439 - 2018-02-06
- FDA Inspection 953462 - 2015-12-11
- FDA Inspection 927014 - 2015-05-21
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