FDA Inspection
St Agnes Healthcare Blood BankSt Agnes Healthcare Blood Bank – FDA Inspection, Feb 4, 2011
Record Details
This FDA Inspection record concerns St Agnes Healthcare Blood Bank, with an inspection on February 4, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 4, 2011
- Product Type
- Biologics
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ID · 241e086e-44f5-4c94-9319-d265e9861f34
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709598
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of St Agnes Healthcare Blood Bank
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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