FDA Inspection
U.S. Navy Medicine Readiness and Training Command Rota SpainU.S. Navy Medicine Readiness and Training Command Rota Spain – FDA Inspection, May 17, 2017
Record Details
This FDA Inspection record concerns U.S. Navy Medicine Readiness and Training Command Rota Spain, with an inspection on May 17, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 17, 2017
- Product Type
- Biologics
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ID · 5e0992af-0c31-488e-8d88-b819049e766e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016453
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 606.121(b)Collection/initial processing facility labels
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.121(c)(13)Unapproved encoded/machine readable information
- 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 U.S. Navy Medicine Readiness and Training Command Rota Spain
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2025 | Not classified | Office of Inspections and Investigations | |
| July 25, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 14, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 1, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 18, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for U.S. Navy Medicine Readiness and Training Command Rota Spain
- FDA Inspection 1279065 - 2025-08-07
- FDA Inspection 1215474 - 2023-07-25
- FDA Inspection 1090197 - 2019-05-14
- FDA Inspection 930574 - 2015-06-01
- FDA Inspection 836851 - 2013-06-18
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