FDA Inspection
Central Shared Services, LLC.Central Shared Services, LLC. – FDA Inspection, Mar 15, 2012
Record Details
This FDA Inspection record concerns Central Shared Services, LLC., with an inspection on March 15, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 15, 2012
- Product Type
- Biologics
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ID · 0c6b838c-f009-40fe-ba7d-b81d8465187d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784062
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)Required records
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 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 |
|---|---|---|---|
| February 28, 2014 | 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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