FDA Inspection
Robley Rex VA Medical CenterRobley Rex VA Medical Center – FDA Inspection, Mar 19, 2010
Record Details
This FDA Inspection record concerns Robley Rex VA Medical Center, with an inspection on March 19, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Robley Rex VA Medical Center
- Inspection Date
- March 19, 2010
- Product Type
- Biologics
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ID · 3f4dc9d7-c016-4f36-809e-af1817087f56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661594
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.122Circular of information - required information
- 21 CFR 606.40(d)(2)Provide adequate disposal of blood & blood components
- 21 CFR 606.171Biological product deviation report
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Robley Rex VA Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 8, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 25, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 3, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Robley Rex VA Medical Center
- FDA Inspection 1239949 - 2024-05-29
- FDA Inspection 1167410 - 2022-04-08
- FDA Inspection 1077764 - 2019-01-25
- FDA Inspection 998342 - 2017-01-13
- FDA Inspection 912478 - 2015-02-03
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