FDA Inspection
Central Shared Services, LLC.Central Shared Services, LLC. – FDA Inspection, Feb 28, 2014
Record Details
This FDA Inspection record concerns Central Shared Services, LLC., with an inspection on February 28, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 28, 2014
- Product Type
- Biologics
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ID · 3d24ae3b-f0f9-4f4d-bff7-1b0225a84569
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868766
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 640.31(b)Criteria for plasmapheresis donor eligibility
- 21 CFR 600.15Blood & Blood Components
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)(10)Controlling storage temperatures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Central Shared Services, LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 16, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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