FDA Inspection
Alabama Organ Center - Mobile RegionAlabama Organ Center - Mobile Region – FDA Inspection, Mar 24, 2011
Record Details
This FDA Inspection record concerns Alabama Organ Center - Mobile Region, with an inspection on March 24, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 24, 2011
- Product Type
- Biologics
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ID · 8802e201-29a9-4ade-8781-eff67b5dfe9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718273
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.190(a)Size, construction, location--prevent mix-ups etc.
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
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Other FDA inspections of Alabama Organ Center - Mobile Region
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 7, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 5, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 5, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Alabama Organ Center - Mobile Region
- FDA Inspection 1072991 - 2018-11-15
- FDA Inspection 993865 - 2016-10-07
- FDA Inspection 905871 - 2014-12-05
- FDA Inspection 820837 - 2013-03-05
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