FDA Inspection
Blood Center of New Jersey, TheBlood Center of New Jersey, The – FDA Inspection, Aug 29, 2013
Record Details
This FDA Inspection record concerns Blood Center of New Jersey, The, with an inspection on August 29, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 29, 2013
- Product Type
- Biologics
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ID · af2f2a99-4994-4483-a404-8d0c977cdbff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 846264
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 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 Blood Center of New Jersey, The
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 11, 2008 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Blood Center of New Jersey, The
- FDA Inspection 747272 - 2011-09-28
- FDA Inspection 555050 - 2008-12-11
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