FDA Inspection
Central Shared Services, LLC.Central Shared Services, LLC. – FDA Inspection, Apr 25, 2011
Record Details
This FDA Inspection record concerns Central Shared Services, LLC., with an inspection on April 25, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 25, 2011
- Product Type
- Biologics
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ID · 14bc83c3-3dbf-4054-bdfb-70aa6e072870
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 720973
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.40(a)(1)Provide space for examination
- 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 Central Shared Services, LLC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 6, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 30, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Central Shared Services, LLC.
- FDA Inspection 903160 - 2014-11-10
- FDA Inspection 823139 - 2013-03-06
- FDA Inspection 584166 - 2009-04-30
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