FDA Inspection
Department of the Army Ireland Army Comm HospDepartment of the Army Ireland Army Comm Hosp – FDA Inspection, Dec 20, 2010
Record Details
This FDA Inspection record concerns Department of the Army Ireland Army Comm Hosp, with an inspection on December 20, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 20, 2010
- Product Type
- Biologics
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ID · 3855b4af-c158-4935-8680-74ff24900e97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702646
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)(6)Required records - transfusion reaction and complaints
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Department of the Army Ireland Army Comm Hosp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 3, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 19, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Department of the Army Ireland Army Comm Hosp
- FDA Inspection 982069 - 2016-08-30
- FDA Inspection 896681 - 2014-09-03
- FDA Inspection 841317 - 2013-07-19
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