FDA Inspection
Moncrief US Army Community Hospital Blood BankMoncrief US Army Community Hospital Blood Bank – FDA Inspection, Aug 19, 2011
Record Details
This FDA Inspection record concerns Moncrief US Army Community Hospital Blood Bank, with an inspection on August 19, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 19, 2011
- Product Type
- Biologics
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ID · 08ab33e0-4aaf-4f55-a487-dcf2c5286d55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745646
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.100(a)SOP compliance
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Moncrief US Army Community Hospital Blood Bank
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 10, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 23, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Moncrief US Army Community Hospital Blood Bank
- FDA Inspection 947313 - 2015-10-28
- FDA Inspection 847684 - 2013-09-10
- FDA Inspection 593828 - 2009-06-23
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